-
Vaccines, Blood & Biologics
-
Resources for You
-
-
General Biologics Guidances
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
-
Administrative
- Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (PDF - 316KB)
9/2009 - Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB)
5/2009 - Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
9/15/2005 - Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria
10/4/2004 - Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
5/28/2004 - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
5/21/2004 - Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
11/24/2003 - Premarket Approval Application Modular Review
11/3/2003
-
-
Adverse Events and Product Deviation Guidances
- Guidance for Clinical Investigators, Sponsors, and IRBs (PDF - 61KB)
1/2009 - Guidance for Clinical Investigators, Sponsors, and IRBs (PDF - 61KB)
1/2009 - Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF - 246KB)
12/2008 - Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports (PDF - 107KB)
6/2008 - Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
10/2006 - Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 52KB)
1/2006 - Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF - 375KB)
3/2001 - Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95KB)
8/1997
-
-
Application Submissions
- SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
10/2009 - Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB)
10/2009 - Providing Regulatory Submissions in Electronic Format – (PDF - 123KB)
5/2009 - Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
12/2008 - Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
11/2008 - Tropical Disease Priority Review Vouchers (PDF - 112KB)
10/2008 - Integrated Summary of Effectiveness (PDF - 95KB)
8/2008 - Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 121KB)
8/2008 - Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 76KB)
8/2008 - Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports (PDF - 107KB)
6/2008 - Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 133KB)
6/2008 - Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
6/2008 - Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
2/2008 - Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF Version) (PDF - 127KB)
2/2008 - Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols (PDF - 76KB)
11/2007 - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions (PDF - 268KB)
10/2007 - Pharmacogenomic Data Submissions — Companion Guidance (PDF - 211KB)
8/2007 - Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission (PDF Version) (PDF - 145KB)
6/2007 - Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 59KB)
6/2007 - Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) (PDF Version) (PDF - 127KB)
10/2006 - Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF Version) (PDF - 82KB)
4/2006 - Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB)
2/2006 - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF - 295KB)
2/2006 - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110KB)
2/2006 - Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB)
2/2006 - How to Comply with the Pediatric Research Equity Act (PDF - 116KB)
9/2005 - Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
5/2005 - Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF version) (PDF - 342KB)
5/2005 - Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF - 28KB)
4/2005 - Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB)
4/2005 - Pharmacogenomic Data Submissions (PDF - 96KB)
3/2005 - Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211KB)
12/2004 - Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
11/2004 - Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria (PDF Version) (PDF - 175KB)
10/2004 - Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) (PDF Version) (PDF - 109KB)
5/2004 - Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
5/2004 - Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (PDF Version) (PDF - 87KB)
11/2003 - Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF - 159KB)
11/2003 - Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA (PDF - 168KB)
10/2003 - Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)
10/2003 - Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products Under PDUFA (PDF - 195KB)
10/2003 - Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 215KB)
8/2003 - Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF - 529KB)
5/2003 - Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
2/2003 - Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
2/2003 - Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff - PDF (PDF - 548KB)
2/2003 - Special Protocol Assessment (PDF - 36KB)
5/2002 - Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF) (PDF - 80KB)
3/2002 - Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
10/2001 - Draft Guidance for Industry - Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research
9/2001 - Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF - 50KB)
8/2001 - Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF - 32KB)
4/2001 - Acceptance of Foreign Clinical Studies (PDF - 12KB)
3/2001 - Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
11/2000 - Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
10/2000 - Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (PDF - 14KB)
10/2000 - Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 30KB)
2/2000 - Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)
2/2000 - Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 57KB)
9/1999 - Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43KB)
8/1999 - Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications (PDF - 582KB)
11/1999 - Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF - 62KB)
10/1998 - Submitting Debarment Certification Statements (PDF - 144KB)
9/1998 - Standards for Prompt Review of Efficacy Supplements (PDF - 76KB)
5/1998 - Classifying Resubmissions in Response to Action Letters (PDF - 76KB)
4/1998 - Pediatric Use Supplements--Content and Format (PDF - 24KB)
5/1996 - Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF - 41KB)
11/1995 - Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
11/1995 - FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability (PDF - 34KB)
7/1995 - Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB)
11/1994 - Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
3/1991
-
-
CMC & GMP
- Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (PDF - 91KB)
11/2008 - Process Validation: General Principles and Practices (PDF - 194KB)
11/2008 - Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 76KB)
8/2008 - Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)
7/2008 - Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms (PDF - 184KB)
9/6/2007 - Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF - 443KB)
9/2006 - Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF - 253KB)
9/2006 - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF - 110KB)
1/2006 - Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
5/2005 - Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (PDF - 734KB)
9/2004 - Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information (PDF - 82KB)
9/2003 - Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
2/2003 - CVM GFI #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB)
9/2002 - Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 15KB)
5/2002 - IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB)
5/2001 - Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 30KB)
3/2001 - Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation (PDF - 91KB)
8/2000 - Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
8/1999 - Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)
5/1999 - Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)
7/1998 - Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
3/1998 - Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (PDF - 44KB)
8/1996 - Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (PDF - 57KB)
11/1994 - Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
12/1987 - Guidance on Alternatives to Lot Release for Licensed Biological Products (PDF - 305KB)
7/14/1993
-
-
Clinical
- Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)
- Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (PDF - 173KB)
- The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 421KB)
- Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB)
- Guidance for Clinical Investigators, Sponsors, and IRBs (PDF - 61KB)
- Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 355KB)
- Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145KB)
- Computerized Systems Used in Clinical Trials (PDF - 53KB)
- Guidance for Clinical Investigators, Sponsors, and IRBs (PDF - 61KB)
- Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF - 253KB)
- Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment (PDF - 205KB)
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
- The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors
- Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB)
- Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB)
- Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70KB)
- Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3151KB)
- Premarketing Risk Assessment (PDF - 88KB)
- Development and Use of Risk Minimization Action Plans (PDF - 225KB)
- Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
- Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB)
- Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211KB)
- Available Therapy (PDF - 176KB)
- Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB)
- Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 40KB)
- IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 188KB)
- Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version) (PDF - 389KB)
- Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222KB)
- Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF - 221KB)
- Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (PDF - 702KB)
- Establishing Pregnancy Exposure Registries (PDF - 268KB)
- Special Protocol Assessment (PDF - 36KB)
- FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB)
- Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
- IDE Financial Disclosure
- Acceptance of Foreign Clinical Studies (PDF - 12KB)
- Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
- Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
- Pediatric Oncology Studies In Response to a Written Request (PDF - 30KB)
- In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44KB)
- Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (PDF - 40KB)
- Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (PDF - 369KB)
- Population Pharmacokinetics (PDF - 135KB)
- FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58KB)
- General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF - 37KB)
- Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129KB)
- Pharmacokinetics in Patients with Impaired Renal Function (PDF - 128KB)
- Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
-
-
Devices
- Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 112KB)
- Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
- Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 196KB)
- Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
- Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF Version) (PDF - 127KB)
- In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions (PDF - 268KB)
- Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version) (PDF - 139KB)
- In Vitro Diagnostic Multivariate Index Assays (PDF version) (PDF - 72KB)
- Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission (PDF Version) (PDF - 145KB)
- Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
- Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
- Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) (PDF Version) (PDF - 127KB)
- Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF Version) (PDF - 82KB)
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
- Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF version) (PDF - 342KB)
- Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
- Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
- Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria (PDF Version) (PDF - 175KB)
- Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s) (PDF Version) (PDF - 109KB)
- Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
- Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF - 159KB)
- Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
- Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version) (PDF - 389KB)
- Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF - 529KB)
- Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff - PDF (PDF - 548KB)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB)
-
-
Labeling & Promotion
- Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 65KB)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387KB)
- Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version) (PDF - 139KB)
- Indexing Structured Product Labeling (PDF - 59KB)
- Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (PDF - 65KB)
- Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
- Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF - 295KB)
- Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 52KB)
- Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 58KB)
- Labeling for Human Prescription Drug and Biological Products — Implementing the New Content and Format Requirements (PDF - 213KB)
- Providing Regulatory Submissions in Electronic Format — Content of Labeling (PDF - 28KB)
- Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB)
- Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use (PDF Version) (PDF - 1385KB)
- Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB)
- “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (PDF - 188KB)
- Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222KB)
- Content and Format for Geriatric Labeling (PDF - 38KB)
- Prescription Drug Advertising and Promotional Labeling (PDF - 28KB)
- In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44KB)
- Consumer-Directed Broadcast Advertisements (PDF - 36KB)
- Accelerated Approval Products —Submission of Promotional Materials (PDF - 17KB)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB)
- Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979KB)
-
-
Subscribe to Updates
-
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
-
-
-