Drugs

Newly Added Guidance Documents

Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

Newly Added Guidance Documents

Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.

CategoryTitleTypeDate
Clinical/Medical Delayed Graft Function in Kidney Transplant: Developing Drugs for Prevention: Guidance for Industry (PDF - 267KB) Draft Guidance 03/22/17
Labeling Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (Expiration date, updated) (PDF - 144KB) Final Guidance 03/14/11
International Council on Harmonisation - Quality Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials. (PDF - 214KB) Draft Guidance 02/17/17
Procedural Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry (PDF - 89KB) Final guidance 02/16/17
Procedural Dear Health Care Provider Letters: Improving Communication of Important Safety Information (PDF - 128KB) Final Guidance 02/08/17
Procedural Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff (PDF - 609KB) Draft Guidance 01/18/17
Small Entity Compliance Guides 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry (PDF - 82KB) Final guidance 01/17/17
Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF - 229KB) Draft Guidance 01/17/17
Clinical/Medical Assessment of Abuse Potential of Drugs (PDF - 285KB) Final Guidance 01/17/17
Procedural Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 134KB) Draft Guidance 01/17/17
Generics Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (PDF - 155KB) Draft Guidance 01/13/17
Generics Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (PDF - 200KB) Draft Guidance 01/13/17
Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 134KB) Revised Final Guidance 01/13/17
Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 112KB) Revised Final Guidance 01/13/17
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 969KB) Draft Guidance, Revised 01/12/17
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF - 646KB) Final Guidance 01/12/17
Generics Guidance for Industry 180-Day Exclusivity: Questions and Answers (PDF - 240KB) Draft 01/12/17
Labeling Nonproprietary Naming of Biological Products Guidance for Industry (PDF - 115KB) Final Guidance 01/12/17
Clinical/Medical Multiple Endpoints in Clinical Trials Guidance for Industry (PDF - 687KB) Draft Guidance 01/12/17
Compliance; Over-the-Counter Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions (PDF - 89KB) Final Guidance 01/11/17
Compliance Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry (PDF - 58KB) Draft Guidance 01/11/17
Procedural Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry (PDF - 111KB) Draft Guidance 01/09/17
Compounding/Procedural Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” (PDF - 191KB) Final 12/30/16
Compounding Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 349KB) Final Guidance 12/28/16
Compounding Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (PDF - 107KB) Draft Guidance 12/28/16
Compounding Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (PDF - 122KB) Draft Guidance 12/28/16
Electronic Submission Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry (PDF - 85KB) Draft Guidance 12/28/16
Pharmaceutical Quality/CMC Botanical Drug Development: Guidance for Industry (PDF - 221KB) Final Guidance 12/28/16
Biosimilarity Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (PDF - 150KB) Final Guidance 12/28/16
Generics ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (PDF - 199KB) Final Guidance 12/21/16
Procedural Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers (PDF - 231KB) Final Guidance 12/14/16
Procedural Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry (PDF - 146KB) Final Guidance 12/08/16
Labeling Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 144KB) Final Guidance 12/02/16
Clinical Pharmacology Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 92KB) Draft Guidance 12/01/16
Drug Safety Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF - 116KB) Final Guidance 11/28/16
Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB) Draft Guidance 11/23/16
Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Final Guidance 11/22/16
Pharmacology / Toxicology Safety Testing of Drug Metabolites (PDF - 185KB) Final Guidance 11/22/16
Over-The-Counter Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data (PDF - 140KB) Final Guridance 11/22/16
Over-The-Counter Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions (PDF - 117KB) Final Guidance 11/22/16
International Council for Harmonization - Efficacy E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (PDF - 124KB) Draft Guidance 11/21/16
User Fees /Generics Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments (PDF - 222KB) Final Guidance 11/21/16
Clinical / Medical BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry (PDF - 178KB) Draft Guidance 11/17/16
Clinical / Medical Non-Inferiority Clinical Trials (PDF - 474KB) Final Guidance 11/07/16

Page Last Updated: 03/22/2017
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