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 / Antimicrobial Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment Guidance for Industry (PDF - 666KB) Draft Guidance 05/03/16
Procedural Special Protocol Assessment Guidance for Industry (PDF - 640KB) Draft Guidance 05/03/16
Pharmaceutical Quality/CMC Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF - 230KB) Draft Guidance 04/22/16
Pharmaceutical Quality/CMC Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry (PDF - 200KB) Draft Guidance 04/19/16
Compounding Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 296KB) (PDF - 295KB) Draft Guidance 04/15/16
Compounding Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 81KB) Draft Guidance 04/15/16
Compounding Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 244KB) Draft Guidance 04/15/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) Draft Guidance 04/14/16
Drug Safety Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry (PDF - 212KB) Final Guidance 04/11/16
Labeling Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 146KB) Final Guidance 04/05/16
Labeling Labeling for Biosimilar Products Guidance for Industry (PDF - 143KB) Draft Guidance 03/31/16
Generics General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry (PDF - 2.3MB) Draft Guidance 03/24/16
Procedural Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Corrected Appendix posted on 3/21/16) (PDF - 138KB) Draft Guidance (corrected Appendix posted on 3/21/16) 03/11/16
Clinical/Medical Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use Guidance for Industry (PDF - 50KB) Draft Guidance 03/08/16
Procedural Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans (PDF - 408KB) Draft Guidance 03/08/16
Pharmaceutical Quality/CMC Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (PDF - 69KB) Final Guidance 03/04/16
Procedural Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry (PDF - 88KB) Final guidance 02/29/16
Pharmaceutical Quality/CMC Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (PDF - 136KB) Final Guidance 02/18/16
Clinical/Medical Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations (PDF - 140KB) Final Guidance 02/18/16
Generics; Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 432KB) Final Guidance 02/12/16
Clinical/Medical Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry (PDF - 309KB) Draft Guidance 02/12/16
Clinical/Medical Nonallergic Rhinitis: Developing Drug Products for Treatment (PDF - 170KB) Draft Guidance 02/12/16
Clinical / Antimicrobial; Animal Rule Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax (PDF - 565KB) Draft Guidance 02/12/16

Page Last Updated: 05/03/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.