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.

 

**JANUARY 2019 GUIDANCES:

IMMUNOGENICITY TESTING OF THERAPEUTIC...

We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  When the FR is available, this document will be available in the FR as will a notice detailing how to submit comments on this document. There is an existing Docket Number, FDA-2009-D-0539, for this document, which is accessible on www.Regulations.gov. 

Labeling for Human Prescription Drugs...

We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  When the FR is available, this document will be available in the FR as will a notice detailing how to submit comments on this document. There is an existing Docket Number, FDA-2018-D-4603, for this document which is accessible on www.Regulations.gov. 

 

 

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
Generics Competitive Generic Therapies Guidance for Industry (PDF - 186KB) Draft Guidance 02/15/19
Procedural CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (PDF - 99KB) Draft Guidance 02/13/19
Clinical / Medical Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry (PDF - 279KB) Draft Guidance 02/06/19
Clinical/Medical Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment (PDF - 262KB) Final Guidance 02/06/19
Rare Diseases Rare Diseases: Common Issues in Drug Development Guidance for Industry  (PDF - 394KB) Draft Guidance (Revised) 01/31/19
Procedural Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry (PDF - 87KB) Draft Guidance 01/30/19
Procedural Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 164KB) Final Guidance 01/29/19
Electronic Submissions Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 121KB) Final Guidance 01/29/19
Procedural REMS Assessment: Planning and Reporting. Guidance for Industry (PDF - 592KB) Draft Guidance 01/24/19
Procedural Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry.  (PDF - 469KB) Draft Guidance 01/24/19
Pharmaceutical Quality/CMC Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry (PDF - 372KB) Final Guidance 01/23/19
International Council for Harmonisation - Safety S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicine (PDF - 1.4MB) Draft Guidance 01/22/19
Labeling Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (PDF - 85KB) Final Guidance 01/22/19
Generics ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Guidance for Industry.  (PDF - 135KB) Draft Guidance 01/16/19
Procedural Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data (PDF - 138KB) Draft Guidance 12/20/18
Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, updated December 2018 Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 225KB) Final Guidance 12/19/18
Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 127KB) Final Guidance 12/12/18
Drug Development Tools Biomarker Qualification: Evidentiary Framework (PDF - 346KB) Draft Guidance 12/11/18
Procedural The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers (PDF - 427KB) Draft Guidance 12/11/18
Procedural Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (PDF - 410KB) Final Guidance 12/11/18
Biosimilarity New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (PDF - 679KB) Draft Guidance 12/11/18
Biosimilars Questions and Answers on Biosimilar Development and the BPCI Act (PDF - 343KB) Final Guidance 12/11/18
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF - 476KB) Draft Guidance 12/10/18
Clinical/Medical Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (PDF - 98KB) Draft Guidance 12/03/18
Generics / User Fees Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA (PDF - 101KB) Final Guidance 12/03/18
Clinical / Medical Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials (PDF - 72KB) Draft Guidance 11/13/18
Drug Safety; Biostatistics Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry (PDF - 227KB) Draft Guidance 11/06/18
Clinical / Medical Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry (PDF - 96KB) Final Guidance 11/06/18

Page Last Updated: 02/15/2019
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