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
Pharmacology/Toxicology Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations (PDF - 85KB) Draft Guidance 09/12/17
Procedural Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry (PDF - 181KB) Draft Guidance 08/18/17
Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products (PDF - 72KB) Final Guidance 08/08/17
Pharmaceutical Quality/CMC CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (PDF - 93KB) Draft Guidance 08/08/17
Labeling Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (PDF - 96KB) Draft Guidance 08/02/17
Clinical/Antimicrobial Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases (PDF - 149KB) Final Guidance 08/01/17
Over-the-Counter; Small Entity Compliance Guides Consumer Antiseptic Wash Final Rule Questions and Answers (PDF - 92KB) Final Guidance 07/25/17
User Fees / Generics Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry (PDF - 131KB) Final Guidance 07/25/17
International Council on Harmonisation - Quality ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents Procedures/Recommendations 07/24/17
International Council on Harmonisation - Quality Q3C Tables and List Rev. 3 (PDF - 185KB) Final Guidance 07/24/17
Q3C Maintenance Procedures (PDF - 94KB) Final Guidance 07/24/17
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4E(R2): The CTD – Efficacy (PDF - 470KB) Final Guidance Revision 1 07/24/17
Procedural Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (PDF - 101KB) Draft guidance 06/30/17
Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Medical Gases (PDF - 219KB) Draft Guidance 06/28/17
Pharmaceutical Quality/CMC ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions Guidance for Industry (PDF - 315KB) Draft Guidance 06/19/17
International Conference on Harmonisation - Efficacy E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for Industry (PDF - 117KB) Final Guidance 06/13/17
Procedural Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF - 226KB) Draft Guidance 04/24/17
Electronic Submissions Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 112KB) Final Guidance 04/07/17
Labeling Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (Expiration date, updated) (PDF - 144KB) Final Guidance 03/14/11
Procedural Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – (PDF - 240KB) Draft Guidance 06/20/17

Page Last Updated: 09/12/2017
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