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
Pharmaceutical Quality/CMC Bispecific Antibody Development Programs Guidance for Industry (PDF - 90KB) Draft Guidance 04/18/19
Drug Safety REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry (PDF - 110KB) Final Guidance 04/04/19
Labeling Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice (PDF - 315KB) Final Guidance 03/27/19
Rare Diseases Rare Diseases: Natural History Studies for Drug Development (PDF - 355KB) Draft guidance 03/22/19
Clinical / Medical Pediatric HIV Infection: Drug Development for Treatment (PDF - 71KB) Final Guidance 03/19/19
Clinical /Antimicrobial Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis (PDF - 91KB) Final Guidance 03/19/19
Procedural A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry (PDF - 118KB) Draft Guidance 03/14/19
Pharmacology / Toxicology Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry (PDF - 122KB) Final Guidance 03/14/19
Clinical/Medical Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (PDF - 576KB) Final Guidance 03/14/19
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Guidance for Industry (PDF - 313KB) Draft Guidance 03/12/19
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients Guidance for Industry (PDF - 286KB) Draft guidance 03/12/19
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies Guidance for Industry (PDF - 281KB) Draft Guidance 03/12/19
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Brain Metastases (PDF - 274KB) Draft Guidance 03/12/19
Clinical / Medical Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials (PDF - 87KB) Final Guidance 03/12/19
Labeling Nonproprietary Naming of Biological Products: Update Guidance for Industry (PDF - 322KB) Draft Guidance 03/07/19
Compounding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 323KB) Final Guidance 02/28/19
Pharmaceutical Quality / CMC Pharmaceutical Quality/Manufacturing Standards (CGPM). Quality Considerations for Continuous Manufacturing Guidance for Industry (PDF - 197KB) Draft Guidance 02/26/19
Clinical Pharmacology Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (PDF - 153KB) Draft Guidance 02/25/19
Clinical Pharmacology Bioavailability Studies Submitted in NDAs or INDs – General Considerations (PDF - 254KB) Draft Guidance 02/25/19
Clinical / Medical Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products Guidance for Industry (PDF - 316KB) Draft Guidance 02/21/19
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

Page Last Updated: 04/18/2019
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