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
Generics	Initial Completeness Assessments for Type II API DMFs Under GDUFA (PDF - 137KB)	Draft Guidance	10/01/12
Clinical Antimicrobial	Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment	Final Guidance	09/28/12
Clinical / Antimicrobial	Complicated Intra-Abdominal Infections: Developing Drugs for Treatment (PDF - 279KB)	Draft Guidance	09/28/12
Generics	Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products	Draft Guidance	09/24/12
Generics	Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations	Draft Guidance	08/22/12
Generics	Guidance for Industry: Generic Drug User Fee Amendments of 2012: Questions and Answers	Draft Guidance	08/22/12
Clinical/Medical	Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials	Revised Draft Guidance	08/14/12
International Conference on Harmonisation - Quality	Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)	Final Guidance	07/25/12
Current Good Manufacturing Practices (CGMPs) - Compliance	Guidance for Industry: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Labeling	Draft Guidance	07/03/12
Clinical/Antimicrobial	Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment	Final Guidance	10/05/12
International Conference on Harmonisation - Efficacy	E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs - Questions and Answers (R1)	Final Guidance	10/12/12
Clinical/Antimicrobial	Guidance for Industry: Acute Bacterial Otitis Media: Developing Drugs for Treatment	Final Guidance	10/01/12