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.

Category	Title	Type	Date
Generic Drug	Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (PDF - 137KB)	Final Guidance	05/05/11
Current Good Manufacturing Practices (CGMPs)/Compliance	Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF - 595KB)	Final Guidance	05/04/11
Drug Safety	Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (PDF - 129KB)	Draft Guidance	04/12/11
Clinical / Antimicrobial	Influenza: Developing Drugs for Treatment and/or Prophylaxis (PDF - 417KB)	Final Guidance	04/12/11
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors on Exception from Informed Consent Requirements for Emergency Research	Exception from Informed Consent Requirements for Emergency Research (PDF - 306KB)	Final Guidance	03/01/11
Drug Safety	Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act (PDF - 276KB)	Final Guidance	03/31/11
Procedural	Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 82KB)	Final Guidance	03/14/11
Current Good Manufacturing Practices (CGMPs)	Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 116KB)	Draft Guidance	03/14/11
Labeling	Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF - 147KB)	Final Guidance	03/14/11
User Fees	User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 256KB)	Draft Guidance	03/11/11
Drug Safety	Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) (PDF - 96KB)	Draft Guidance	02/25/11
Clinical Pharmacology	Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies (PDF - 531KB)	Draft Guidance	02/17/11
Drug Safety	Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 316KB)	Draft Guidance	02/16/11
Procedural; Modernization Act	PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (PDF - 399KB)	Draft Guidance	02/02/11
Procedural Modernization Act	PET Drug Applications — Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 (PDF - 556KB)	Draft Guidance	02/02/11
Procedural; Modernization Act	PET Drug Applications — Content and Format for NDAs and ANDAs: Attcahment II: Sample formats for Form FDA 356h_2011 (PDF - 601KB)	Draft Guidance	02/02/11
	PET Drug Applications — Content and Format for NDAs and ANDAs: Sample Labels in SPL Format. Positron Emission Tomography (PET) Drug SPL