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
Generics Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry (PDF - 82KB) Final Guidance 09/22/16
Drug Safety FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry (PDF - 129KB) Draft Guidance 09/20/16
International Council for Harmonisation - Safety S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers (PDF - 190KB) Draft Guidance 09/16/16
Drug Development Tools Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry (PDF - 32KB) Final Guidance 09/15/16
Drug Development Tools Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry (PDF - 39KB) Final Guidance 09/14/16
International Council for Harmonisation - Efficacy E17 General Principles for Planning and Design of Multi-Regional Clinical Trials (PDF - 359KB) Draft Guidance 09/08/16
International Council for Harmonisation - Safety S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic (PDF - 181KB) Draft Guidance 09/08/16
Clinical / Antimicrobial Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF - 423KB) Final Guidance 08/25/16
Generics ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits (PDF - 326KB) Final Guidance 08/24/16
Pharmaceutical Quality - CMC Regulatory Classification of Pharmaceutical Co-Crystals- Draft (PDF - 82KB) Draft Guidance 08/16/16
Clinical / Medical Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry (PDF - 565KB) Draft 08/05/16
Compounding Insanitary Conditions at Compounding Facilities Guidance for Industry (PDF - 95KB) Draft Guidance 08/03/16
International Council on Harmonisation- Efficacy E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) (PDF - 462KB) Final Guidance 07/18/16
International Conference on Harmonization - Efficacy E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers (PDF - 153KB) Final Guidance 07/18/16
Clinical / Antimicrobial Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry (PDF - 290KB) Draft Guidance 07/13/16
Generics Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (PDF - 94KB) Draft Guidance 07/08/16
Compounding Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 108KB) Draft Guidance 07/07/16
Compounding Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 348KB) Draft Guidance 07/07/16
Pharmaceutical Quality/CMC Elemental Impurities in Drug Products (PDF - 100KB) Draft Guidance 06/30/16
Clinical / Antimicrobial Vulvovaginal Candidiasis: Developing Drugs for Treatment (PDF - 163KB) Draft Guidance 06/30/16
Clinical / Medical Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention (PDF - 452KB) Draft Guidance 06/30/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Technical Specifications Document: "Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF - 114KB) Draft Guidance 06/24/16
Pharmaceutical Quality/CMC Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 121KB) Draft Guidance 06/16/16
Pharmacology/Toxicology. Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry (PDF - 146KB) Draft Guidance 06/13/16
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 - 127KB) Final Guidance 06/09/16
Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 227KB) Final Guidance 06/09/16
Compounding; Procedural Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 85KB) Final Guidance 06/09/16
Procedural Charging for Investigational Drugs Under an IND — Qs & As (PDF - 87KB) Final Guidance 06/02/16
Procedural Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF - 180KB) Final Guidance 06/02/16
Procedural Individual Patient Expanded Access Applications: Form FDA 3926 (PDF - 88KB) Final Guidance 06/02/16
ICH - Efficacy E18 Genomic Sampling and Management of Genomic Data (PDF - 171KB) Draft Guidance 06/02/16
Generics Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry (PDF - 189KB) Draft Guidance 05/31/16
Clinical / Medical Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (PDF - 388KB) Draft Guidance 05/19/16
Procedural Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry (PDF - 247KB) Draft Guidance 05/16/16
Procedural Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry (PDF - 126KB) Final Guidance 05/13/16
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

Page Last Updated: 09/22/2016
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