CDER Small Business & Industry Assistance (SBIA)
Calendar of Upcoming Events
Date | Event | Location |
---|---|---|
May 14, 2021 | FDA and Health Canada Regional ICH Consultation | Webcast |
May 21, 2021 | FDA Study Data Technical Rejection Criteria (TRC): What you need to know! | Webcast |
June 11, 2021 | Identification of Medicinal Products: Path to Global Implementation | Webcast |
Jun. 23, 2021 | FY 2021 Generic Drug Science and Research Initiatives Public Workshop | Webcast |
Pre-Clinical through Investigational New Drug Application (IND)
- In the Topic dropdown on the FDA Guidance page, select ICH-Safety or Pharm/Tox
Clinical Trials
- Drug Development Process
- Clinical Trials and Human Subject Protection
- Phases of Human Clinical Trials
- Drug Approval Process Infographic
- How to Request Single Patient Expanded Access
- A Guide to Non-Emergency Single Patient Expanded Access Submissions
Developing and Manufacturing Drugs Including Biologics
Engaging with FDA
- Enhanced Communication Team
- Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- Engaging with FDA during New Drug Development Course
- Pre-IND Meeting FAQs
- Best Practices for Communication with FDA
IND Submissions
- Exploratory INDs
- Investigator-Initiated INDs and IND submission procedures
- IND Exemptions
- Expedited Programs
Regulatory Submissions
- Regulations: 21 CFR 314 and 21 CFR 601
- Inactive Ingredient Database
- Physician Labeling Rule (PLR)
Therapeutic Biologics
- Deemed to be a License” Provision of the BPCI Act
- Transfer of Therapeutic Products to CDER
- Therapeutic Biologic Applications (BLA) Approval Information
Meetings
- Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- Engaging with FDA during New Drug Development Course
- Advisory Committee meeting
NDA Submission and Fees
- NDA Resources
- 505(b)(2) Applications
- Prescription Drug User Fee Act (PDUFA)
- User Fee Waivers, Reduction, and Refunds for Drug and Biological Products
- Combination Products
Regulatory Submissions
ANDA Submission Requirements
- Activities Report of the Generic Drugs Program Monthly Performance
- Generic Drug Guidances
- Referencing Approved Drug Products in ANDA Submissions Guidance for Industry
- Patent Certifications and Suitability Petitions
- Guidance for Industry: ANDA Submission - Content and Format of ANDAs
- Generic Drugs: Information for Industry
- ANDA Forms and Submissions Requirements
GDUFA
- GDUFA webpage
- GDUFA web-based learning courses
- Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry
- Self-Identification of Generic Drug Facilities, Sites and Organizations
- Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry
Communications and Electronic Submissions
- CDER Direct NextGen Collaboration Portal
- Controlled Correspondence
- Electronic Regulatory Submission and Review
- Forms and Submission Requirements
- Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
- Pre-ANDA Program
- Electronic Drug Registration and Listing Instructions
Additional Resources
- CDERLearn Course – Bringing OTC to Market
- Drug applications for OTC products
- Electronic Drug Registration and Listing Instructions
- OTC Drug Product Review Process
- OTC Monographs
- Over-the-Counter Monograph User Fee Program (OMUFA)
- Webinar: Monograph reform is here! Learn what to expect and how to prepare - May 29, 2020
- Biosimilars
- Biosimilars Guidances (search Biosimilars under topic)
- Biosimilars Action Plan
- Biosimilar User Fee Act (BsUFA)
- Biosimilar Product Information
- Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
- FDA Webinar - FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US
- Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
- Developing Products for Rare Diseases & Conditions
- Frequently Asked Questions About Therapeutic Biological Products
- Frequently Asked Questions (FAQ) About Designating an Orphan Product
- NIH Office of Rare Diseases Research
- Orphan Products Grants Program
- Rare Diseases Guidance Documents
- Search Orphan Drug Designations and Approvals
Compliance
Compounding
Current Good Manufacturing Practices (CGMPs)
- CGMP Guidance Documents (search under Pharmaceutical Quality/Manufacturing Standards (CGMP)
- CGMP Regulations
- Facts About CGMPs
- Inspections, Compliance, Enforcement, and Criminal Investigations
- Questions and Answers on CGMPs
Drug Master Files
- Drug Master File webpage
- Type II DMFs for Active Pharmaceutical Ingredients
- SBIA Webinar: New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016
Drug Supply Chain
Import/Export
Office of International Programs
Office of Regulatory Affairs
- Inspections, Compliance, Enforcement, and Criminal Investigations
- Office of Regulatory Affairs (ORA) Directory (PDF - 1 MB)
Pharmaceutical Quality
- Pharmaceutical Quality/CMC Guidances
- CGMP Guidance Documents (search under Pharmaceutical Quality/Manufacturing Standards (CGMP)
- Quality Metrics for Drug Manufacturing
- Drug Quality Sampling and Testing Programs
- Pharmaceutical Quality Resources
Registration and Drug Listing
- Prescription Drug Labeling Resources – Labeling resources for the Prescribing Information, FDA-approved patient labeling, and carton and container labeling for human prescription drugs
- SBIA Prescription Drug Labeling Conference 2019
- SBIA Prescription Drug Labeling Conference 2017
- SBIA Prescription Drug Labeling Conference - Challenges and Issues 2015
(866) 405-5367
(301) 796-6707
CDERSBIA@fda.hhs.gov
CDER SBIA
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
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