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
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Pharmacology Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 92KB) Draft Guidance 12/01/16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Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB) Draft Guidance 11/23/16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- Efficacy E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (PDF - 124KB) Draft Guidance 11/21/16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Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry (PDF - 178KB) Draft Guidance 11/17/16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
Clinical - Medical Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry (PDF - 298KB) Draft Guidance 10/25/16
Generics ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 176KB) Final Guidance 10/14/16
Over-the-Counter Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process (PDF - 103KB) Final Guidance 10/07/16
Over-The-Counter Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry (PDF - 105KB) Final Guidance 10/07/16
Procedural Tropical Disease Priority Review Vouchers (PDF - 193KB) Final Guidance 10/05/16
Clinical /Medical Head Lice Infestation: Developing Drugs for Topical Treatment Guidance for Industry (PDF - 233KB) Final Guidance 10/05/16
International Council on Harmonisation - Quality Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry (PDF - 253KB) Final Guidance 09/30/16
Generics Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry (PDF - 268KB) 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

Page Last Updated: 12/02/2016
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