• December 19, 2019: Final guidance - Considerations for the Development of Dried Plasma Products Intended for Transfusion. This guidance provides recommendations for the development of safe and effective dried plasma products intended for transfusion; it finalizes the guidance of the same title dated October 2018.

• December 19, 2019: Draft guidance - Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products - To provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness. Comment by February 21, 2020.

• December 13, 2019: Draft guidance - Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff - Provides FDA’s current thinking regarding the qualification process for drug development tools (DDTs) for a specific use, as defined in the 21st Century Cures Act. Qualification is a voluntary process that permits use of a DDT for its context of use— the defined boundaries within which the available data justifies use of the DDT(s)—across multiple drug development programs. DDTs are methods, materials, or measures that have the potential to facilitate drug development, including, for example, an animal model used for efficacy testing of medical countermeasures under the Animal Rule. Comment by February 12, 2020.

• December 6, 2019: FDA published a new web page, Availability of Regulatory Management Plans. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as amended by the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA), furthered FDA’s mission of fostering the development and availability of medical countermeasures (MCMs) by codifying the development of Regulatory Management Plans (RMPs) for certain high-priority MCMs. Under section 565(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act, sponsors or applicants of eligible MCMs can request an RMP, setting forth a formal process for obtaining scientific feedback and agency interactions regarding the development and regulatory review of eligible MCMs. This page provides information about RMPs for MCM sponsors or applicants. Also see: MCM-Related Counterterrorism Legislation

• November 29, 2019: Final guidance - Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry - Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The guidance provides information to sponsors submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance also advises sponsors on the types of information to submit to facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design.

• November 15, 2019: Final guidance - Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention - designed to assist drug manufacturers designing studies to appropriately establish the safety and efficacy of drugs to treat or prevent smallpox infection Also see: FDA In Brief: FDA issues final guidance for development of smallpox treatments as part of critical preparedness efforts

• November 6, 2019: Draft guidance - Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff - The 21st Century Cures Act (Cures Act), enacted on December 13, 2016, requires that FDA make publicly available on its website best practices for drug safety surveillance activities. The draft document sets forth risk-based principles by which FDA conducts ongoing postmarketing safety surveillance for drug and biological products to address the Cures Act requirements. Comment by January 6, 2020. Also see: Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

• October 29, 2019: Draft guidance - Providing Regulatory Submissions in Electronic Format: IND Safety Reports - Describes the electronic format sponsors will be required to use when they electronically submit to FDA investigational new drug application (IND) safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 21 CFR 312.32(c)(1)(i). Comment by December 30, 2019. Also see: FDA Adverse Event Reporting System (FAERS) Electronic Submissions

• October 18, 2019: Revised draft guidance - Drug Master Files Guidance for Industry - Provides FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types of information as well (e.g., toxicology information, shared system REMS (risk evaluation and mitigation strategy)). Comment by December 18, 2019.

• October 18, 2019: FDA's Center for Drug Evaluation and Research (CDER) invites pharmaceutical companies interested in participating in the Fiscal Year 2020 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program to submit a site visit proposal. OPQ encourages companies engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to respond. Submit proposals by November 18, 2019.

• October 16, 2019: Guidance - Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review - This technical specifications document provides the sponsor/applicant detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications. FDA recommends submission of these datasets as part of the applicant’s data tabulation datasets. 

• September 20, 2019: Draft guidance - Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products - Provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial design (CID) proposals for drugs or biological products.   FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the 21st Century Cures Act (Cures Act).  In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review. Comment by December 23, 2019.

• September 12, 2019: Final guidance - The Special 510(k) Program - To describe an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence. This guidance clarifies the types of technological changes appropriate for review as Special 510(k)s.

• September 6, 2019: Final guidance - Acceptance Review for De Novo Classification Requests - To explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (de novo classification request or de novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This guidance also includes a De Novo Acceptance Checklist and a Recommended Content Checklist.

• August 30, 2019: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. Nominations received on or before October 29, 2019 will be given first consideration.

• August 29, 2019: Final guidance - Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Describes the FDA’s consideration of uncertainty when determining benefit-risk for certain premarket decisions on medical devices based on the totality of the valid scientific evidence, and outlines a rigorous, methodical approach for the consideration of uncertainty when assessing the benefits and risks of a medical device and for determining when it may be appropriate to shift some data collection from the premarket to the postmarket phase. On October 16, 2019, FDA will host a webinar for stakeholders interested in learning more about this final guidance.  FDA also updated the guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, which describes the principal factors, including uncertainty of benefits and risks, the FDA considers when making benefit-risk determinations for certain premarket decisions. Appendices B and C of this guidance are updated with a revised Benefit-Risk Determination Worksheet that incorporates the same factors for benefit-risk determinations described in the guidance. The revised worksheet provides structure to guide and organize the benefit-risk factors and to support consistent decision-making.

• August 21, 2019: FDA released the updated version of the Clinical Outcome Assessment Compendium (COA Compendium) to encourage the development and implementation of patient-focused clinical outcome assessments (COAs) in clinical trials to support drug approvals and labeling claims. The COA Compendium is a communication tool that organizes and summarizes COA information for many different diseases and conditions into a single resource. FDA hopes this will facilitate communication with industry and researchers and provide clarity and transparency to drug developers and the research community. The COA Compendium is intended to be used as a starting point when considering how COAs might be utilized in clinical trials and will likely be most informative early in drug development.

• August 20, 2019: FDA is requesting nominations for voting members to serve on the Blood Products Advisory Committee. Nominations received on or before October 21, 2019 will be given first consideration.

• August 7, 2019: FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the VRBPAC. Letters of interest/nomination materials are due by September 6, 2019.

• July 31, 2019: Draft guidance - E8(R1) General Considerations for Clinical Studies - The draft guidance, was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and  describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, the draft guidance provides an overview of the types of clinical studies that sponsors may perform and data sources they may use during the product’s life cycle. The draft guidance intends to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility. Comment by September 30, 2019.

• July 24, 2019: FDA in Brief: FDA seeks public feedback on biomarker and study endpoint glossary -  FDA issued a Federal Register notice, 21st Century Cures: Announcing the Establishment of the BEST Resource Taxonomy, to open a docket for public comment. In 2015, the FDA-NIH (National Institutes of Health) Joint Leadership Council identified the harmonization of terms used in translational science and medical product development as a priority need, with a focus on terms related to study endpoints and biomarkers. This resulted in the BEST glossary of terms. The FDA is seeking comments concerning the utility of BEST; including edits, additions and removal of terms along with a rationale supporting these proposed changes. Comment by September 23, 2019. Also see: BEST Resource Taxonomy

• July 18, 2019: Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document - The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antiviral Products in regard to the submission of next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drug products. Providing accurate resistance information is imperative for protecting public health to prevent the emergence of novel resistant and cross-resistant viral variants that have the potential to infect others and cause major outbreaks of disease that cannot be controlled by approved drug products.

• July 9, 2019: Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry - This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS.

• July 8, 2019: The Center for Devices and Radiological Health (CDRH) 2020 Experiential Learning Program site visit proposal solicitation period is open until 12:00 p.m. August 8, 2019. CDRH is inviting medical device companies, academia, and health care facilities to participate in this formal training program.  

• June 28, 2019: FDA announced the availability of a draft guidance for industry, M10 Bioanalytical Method Validation, that was developed by the International Council for Harmonisation. The draft guidance describes the various elements and expectations to validate specific tests used to measure the parent and active metabolites of drugs administered in nonclinical and clinical studies submitted in regulatory applications for biological matrices such as plasma, blood, or serum. Comment by August 26, 2019.

• June 28, 2019: FDA issued a proposed rule to amend its regulations concerning the use of master files for biological products. Comment by August 27, 2019. Also see: “Deemed to be a License” Provision of the BPCI Act and FDA In Brief: FDA takes new step to help advance the transition of certain biological products

• June 26, 2019: FDA In Brief: FDA seeks public feedback on new drug approval transparency efforts - FDA issued a Federal Register notice, New Drugs Regulatory Program Modernization: Improving Approval Package Documentation, to open a docket for public comment as part of the agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process for drug and biological products assessed by the FDA’s Center for Drug Evaluation and Research (CDER). The notice specifically asks for feedback on the Clinical Data Summary Report (CSR) Pilot Program and the new integrated review of marketing applications process and documentation template. Comment by August 26, 2019.

• June 26, 2019: FDA has published a series of presentations to educate and inform stakeholders on Complex Innovative Trial Designs (CID) and the CID Pilot Meeting Program and application process. The CID Pilot program is designed to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. The program offers sponsors an opportunity for increased interaction with the FDA to discuss their proposed CID.

• June 6, 2019: Draft guidance: Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs -  Provides recommendations for more inclusive trial practices, trial designs, and methodological approaches sponsors can take to broaden eligibility criteria and increase enrollment of more diverse populations in clinical trials. Broadening eligibility criteria, when appropriate, maximizes the generalizability of trial results and the ability to understand the therapy’s benefit-risk profile across the patient population likely to use the drug in clinical practice, without jeopardizing patient safety. Comment by August 6, 2019.

• May 8, 2019: Draft guidance: Submitting Documents Utilizing Real-World Data (RWD) and Real-World Evidence (RWE) to the FDA for Drugs and Biologics. This draft guidance encourages sponsors and applicants who are using RWD to generate RWE as part of a submission to provide information on their use of RWE to the FDA in a simple, uniform format. The FDA will use this information for internal tracking purposes only. Comment by July 8, 2019. Also see: FDA In Brief: FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications

• April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This finalizes the draft guidance published on April 25, 2017. (Federal Register notice) More on Expiration Dating Extension

• April 2, 2019: FDA announced that it is exploring a framework that would allow for modifications to artificial intelligence and machine learning algorithms to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained. Comment on the discussion paper (PDF, 1.6 MB) by June 3, 2019. Also see: Artificial Intelligence and Machine Learning in Software as a Medical Device

• April 2, 2019: FDA's Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). Interested pharmaceutical companies may send proposed agendas to CDER by June 3, 2019.

• April 1, 2019: FDA has posted a Compliance Program for the Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies (CP 7348.007) on its Bioresearch Monitoring Program (BIMO) Compliance Programs web page. This compliance program provides instructions for the inspection of nonclinical laboratories conducting the Animal Rule-specific studies (i.e., the natural history studies that define the animal model in which the efficacy of an investigational drug or biological product will be tested, the adequate and well-controlled animal efficacy studies intended to provide the primary evidence of effectiveness to support marketing approval of the product, and the pharmacokinetic and/or pharmacodynamic studies in animals used to select a dose and regimen in humans). Inspections of these studies are conducted to verify, to the extent practicable, the quality and integrity of the data contained in the final reports of the Animal Rule-specific studies submitted to FDA.

• March 29, 2019: FDA finalizes requirements to help foster access to safe and effective tests to detect anthrax-causing bacteria - FDA issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus bacteria into class II (special controls) and continuing to require a premarket notification (510(k)) for these devices. This final rule and the accompanying special controls guideline will help assure manufacturers continue to use appropriate practices for these devices and provide consistent information on testing criteria and performance evaluations for bringing safe and effective new Bacillus bacteria detection devices to market. Bacillus bacteria detection devices are prescription devices that provide a preliminary identification of Bacillus anthracis and other Bacillus species to help diagnose cases of anthrax and other diseases caused by Bacillus bacteria. These devices were previously unclassified preamendments devices that were legally marketed prior to May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act were signed into law.

• March 28, 2019: Guidance - Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling - To assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. This guidance finalizes the draft guidance issued on February 28, 2013.

• March 26, 2019: Guidance - Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research - Provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in CBER's managed review process. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2017. (Federal Register notice)

• March 25, 2019: Draft guidance - Rare Diseases: Natural History Studies for Drug Development - To help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. Comment by May 24, 2019. Also see: FDA In Brief: FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases

• March 14, 2019: Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development - FDA is releasing guidance for industry on strategies that can support the development of precision medicines, and guidance on risk-based monitoring that can be accomplished through the incorporation of more computerized systems for effective oversight. These guidances, Enrichment Strategies for Clinical Trials to Support Determinations of Effectiveness of Human Drugs and Biological Products , and A Risk Based Approach to Monitoring of Clinical Investigations: Questions and Answers (PDF, 118 KB - submit comments by May 14, 2019), can help facilitate efficient development of novel innovations, while also generating the robust evidence needed to better assess product safety and efficacy.

• March 7, 2019: Draft guidance: Nonproprietary Naming of Biological Products: Update - Describes FDA’s current thinking that the nonproprietary names of biological products licensed under section 351 of the Public Health Service Act without an FDA-designated suffix do not need to be revised to add a suffix to accomplish the objectives of the naming convention described in the final guidance for industry on Nonproprietary Naming of Biological Products (Naming Guidance), issued in January 2017. Comment by May 7, 2019. (Federal Register notice) Also see: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

• February 28, 2019: Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World - The Centers for Disease Control and Prevention (CDC) has changed information on its Blood and Tissue Safety webpage used to communicate epidemiological information about Zika virus (ZIKV) to the blood and tissue collection community. The webpage includes a world map of areas with risk of Zika for other countries and territories outside of U.S. states. A new process has been developed to indicate risk for these areas that assigns one of four categories. FDA considers countries and territories outside the U.S. states categorized as “Red” (current outbreak) or “Purple” (any prior or current reports of mosquito-borne Zika transmission) as areas with increased risk of ZIKV transmission. Also see: Guidance for Industry: Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products (updated May 2018)

• February 26, 2019: Draft guidance - Quality Considerations for Continuous Manufacturing, to clarify the FDA’s current thinking regarding innovative CM approaches and can help resolve potential issues some companies have as they consider implementation. Comment by May 28, 2019 (Federal Register notice). Also see: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing

• February 25, 2019: FDA is reopening the comment period for the proposed rule entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” that appeared in the Federal Register of November 15, 2018.  FDA is taking this action due to technical difficulties at the Federal eRulemaking portal.  Comments on the proposed rule may be submitted at  https://www.regulations.gov (Docket No. FDA-2018-N-2727) and are now due by March 7, 2019.

• February 21, 2019: FDA Resources for Implementing Final Rule on Human Subject Protection - FDA is reminding stakeholders that today is the effective date for compliance with the final rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices. The rule updates the standards for accepting clinical data from clinical investigations conducted inside and outside the United States to protect human participants, and to help ensure the quality and integrity of data obtained through such investigations. On March 19, 2019, FDA will host a webinar for stakeholders who want to learn more about the implementation of this final rule. Also see: Acceptance of Data from Clinical Investigations for Medical Devices

• February 12, 2019: Electronic data standards for Animal Rule studies - notice of upcoming comment periods and webinar - FDA has been working with the Critical Path Institute  and the Clinical Data Interchange Standards Consortium (CDISC) to develop electronic data standards for the natural history and efficacy studies conducted in animals that support Animal Rule applications. The draft Standard for Exchange Nonclinical Data (SEND) Implementation Guide for Animal Rule studies (SENDIG-AR) will be available for public review and comment on the CDISC website by February 25, 2019, with the comment period closing on April 29, 2019. A free webinar providing an overview of the SENDIG-AR is scheduled for March 5, 2019, 11:00 a.m. – 12:30 p.m. ET. A webinar recording is available.

• February 7, 2019: FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines - DSCSA Pilot Project Program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. FDA will be accepting applications for participation in the DSCSA Pilot Project Program through March 11, 2019. More on how to participate

• February 5, 2019: Draft guidance - Principles of Premarket Pathways for Combination Products -  Presents the current thinking of the FDA on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate, including new drug applications or abbreviated new drug applications for drug-led combination products; stand-alone or biosimilar biologics license applications for biologic-led combination products, and 510(k), De Novo or premarket approval applications for device-led combination products. Comment by May 7, 2019. (Federal Register notice) Also see: FDA in Brief: To advance efficient development and review of combination products, the FDA outlines principles to promote a more predictable premarket review pathway

• February 5, 2019: Guidance - The Least Burdensome Provisions: Concept and Principles (PDF, 483 KB) - Describes FDA's use of the least burdensome approach to medical device regulation to remove or reduce unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. (Federal Register notice) FDA will host a webinar about this final guidance on March 14, 2019, 1:00 - 2:30 p.m. ET. Also see: FDA In Brief: FDA takes new steps to modernize the ‘least burdensome’ concept and principles applicable to its medical device regulatory framework to advance beneficial innovations to patients more efficiently while improving assurance of safety

• February 4, 2019: FDA's Center for Devices Radiological Health (CDRH) Experiential Learning Program (ELP) is seeking sites to participate in 2019 training site visits. The 2019 Spring ELP submission period is open from February 4, 2019 to March 4, 2019 at 12:00 p.m. ET.

• January 31, 2019: The HHS Secretary is amending the December 3, 2014 PREP Act Declaration for Ebola Virus Disease Vaccines to update the term “Ebola Virus Disease” throughout the declaration and to clarify the definition of EBOD. The amendment also expands the Covered Countermeasures beyond the three vaccines listed in prior declarations but limit coverage to Covered Countermeasures that are directly supported by the U.S. Federal Government, consistent with the terms of the Declaration, and is republishing the Declaration in its entirety as amended.

• January 31, 2019: The HHS Secretary is amending the February 27, 2015 PREP Act Declaration for Ebola Virus Disease Therapeutics to update the term “Ebola Virus Disease” to “Ebola disease” (EBOD) throughout the declaration and to clarify the definition of EBOD. The amendment also expands the Covered Countermeasures beyond the single therapeutic listed in prior declarations but limit coverage to Covered Countermeasures that are directly supported by the U.S. Federal Government, consistent with the terms of the Declaration, and is republishing the Declaration in its entirety as amended.

• January 25, 2019: If you missed the January 17, 2019 webinar Breakthrough Devices Program Final Guidance, printable slides, video and a transcript are available.

• January 24, 2019: FDA issued two guidances that aim to bring clarity to the assessment of risk evaluation and mitigation strategies (REMS) programs. These guidances, REMS Assessment: Planning and Reporting Guidance for Industry (PDF,  590 KB) (Federal Register notice) and Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry (PDF,  463 KB) (Federal Register notice) will assist sponsors in assessing the effectiveness of REMS programs. Comment by April 2, 2019 using the Federal Register notice links for each draft guidance. Also see: FDA statement from Commissioner Scott Gottlieb, M.D. announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications

• January 23, 2019: Guidance - Immunogenicity Testing of Therapeutic Protein Products--Developing and Validating Assays for Anti-Drug Antibody Detection (PDF, 371 KB) - Provides recommendations to facilitate industry’s development and validation of immune assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. The recommendations for assay development and validation provided in this document apply to assays for the detection of one or more anti-drug antibodies.  This document also includes updated information on the development and validation of screening assays, confirmatory assays, titering assays, and neutralization assays, as well as an additional discussion of immunogenicity risk assessment. (Federal Register notice)

• January 23, 2019: Draft guidance - S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines (PDF, 1.4 MB)  This guidance, which was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), recommends international standards for the nonclinical safety studies recommended to support the development of pediatric medicines. Comments may be submitted to the ICH Secretariat by sending an email to [email protected]. Submit comments to FDA by April 2, 2019 (instructions in the Federal Register notice).

• January 23, 2019: Guidance - Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway - To assist applicants in developing the Indications and Usage section of labeling for human prescription drug and biological products approved under the accelerated approval regulatory pathway, specifically indications for drugs approved via accelerated approval on the basis of a surrogate endpoint or a clinical endpoint other than survival or irreversible morbidity. (Federal Register notice)

• January 17, 2019: Guidance - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - To minimize time between the approval of new antimicrobial drugs and clearance of antimicrobial susceptibility tests used to determine the potential effectiveness of those drugs; and provide recommendations to the medical device and drug industries on how to work together to facilitate timely clearance of antimicrobial susceptibility test devices by the FDA. FDA will discuss this final guidance at a webinar scheduled for February 12, 2019. (Federal Register notice)

For MCM-related guidance and announcements from 2018, please visit this archive page

For MCM-related guidance and announcements from 2017, please visit this archive page