http://www.fda.gov/ en http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia A Comprehensive Resource for Information on Human Drug Development in Regulation Wed, 01 Feb 2023 15:53:24 EST FDA http://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance-sbia http://www.fda.gov/about-fda/user-fee-performance-reports/pdufa-performance-reports PDUFA Performance Reports Wed, 01 Feb 2023 15:43:56 EST FDA http://www.fda.gov/about-fda/user-fee-performance-reports/pdufa-performance-reports http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Wed, 01 Feb 2023 15:19:25 EST FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. Wed, 01 Feb 2023 15:07:53 EST FDA http://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ibsa-pharma-inc-issues-voluntary-nationwide-recall-select-lots-tirosintr-sol-levothyroxine-sodium IBSA Pharma Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxin Wed, 01 Feb 2023 14:44:42 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ibsa-pharma-inc-issues-voluntary-nationwide-recall-select-lots-tirosintr-sol-levothyroxine-sodium http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. Wed, 01 Feb 2023 14:24:51 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education Continuing Education and Training opportunities for healthcare professionals, academia, students and consumers. Wed, 01 Feb 2023 12:35:52 EST FDA http://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education http://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic. Wed, 01 Feb 2023 12:22:17 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document http://www.fda.gov/regulatory-information/search-fda-guidance-documents/m13a-bioequivalence-immediate-release-solid-oral-dosage-forms M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Draft Guidance for Industry Wed, 01 Feb 2023 11:56:52 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/m13a-bioequivalence-immediate-release-solid-oral-dosage-forms http://www.fda.gov/drugs/news-events-human-drugs/best-practices-topical-generic-product-development-and-anda-submission-08112022 Best Practices for Topical Generic Product Development and ANDA Submission Wed, 01 Feb 2023 11:13:16 EST FDA http://www.fda.gov/drugs/news-events-human-drugs/best-practices-topical-generic-product-development-and-anda-submission-08112022 http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Office of Patient Affairs draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions. Wed, 01 Feb 2023 11:05:15 EST FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-listening-session-summaries http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists Generic Drug Facilities, Sites and Organization Lists Wed, 01 Feb 2023 09:21:50 EST FDA http://www.fda.gov/industry/generic-drug-user-fee-amendments/generic-drug-facilities-sites-and-organization-lists http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months. Tue, 31 Jan 2023 18:26:36 EST FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Tue, 31 Jan 2023 17:16:08 EST FDA http://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals http://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-guidance-help-increase-supply-ibuprofen-oral-suspension-products-hospitals-and-health FDA is issuing an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to improve the supply of pediatric ibuprofen amid record high demand. Tue, 31 Jan 2023 16:35:17 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-guidance-help-increase-supply-ibuprofen-oral-suspension-products-hospitals-and-health http://www.fda.gov/drugs/drug-safety-and-availability/la-fda-publica-una-guia-para-ayudar-aumentar-el-suministro-de-ibuprofeno-en-suspension-oral-en La FDA publica una guía para ayudar a aumentar el suministro de ibuprofeno en suspensión oral en hospitales y centros de salud Tue, 31 Jan 2023 16:34:52 EST FDA http://www.fda.gov/drugs/drug-safety-and-availability/la-fda-publica-una-guia-para-ayudar-aumentar-el-suministro-de-ibuprofeno-en-suspension-oral-en http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. Tue, 31 Jan 2023 16:22:15 EST FDA http://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities http://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making. Tue, 31 Jan 2023 15:48:13 EST FDA http://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence http://www.fda.gov/drugs/science-and-research-drugs/drug-quality-sampling-and-testing-programs FDA CDER's quality sampling and testing programs assess pharmaceutical quality after drugs are on the market. Tue, 31 Jan 2023 15:32:23 EST FDA http://www.fda.gov/drugs/science-and-research-drugs/drug-quality-sampling-and-testing-programs http://www.fda.gov/regulatory-information/search-fda-guidance-documents/acromegaly-developing-drugs-treatment Acromegaly: Developing Drugs for Treatment Tue, 31 Jan 2023 15:13:13 EST FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/acromegaly-developing-drugs-treatment