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	Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products (PDF - 30KB)	Final Guidance	06/19/13
Clinical/Medical	Codevelopment of Two or More New Investigational Drugs for Use in Combination (PDF - 91KB)	Final Guidance	06/14/13
Clinical/Antimicrobial	Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (PDF - 801KB)	Draft (revised final)guidance	06/04/13
International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)	M2: eCTD Specification Questions & Answers and Change Requests Companion Document	Final Guidance	06/03/13
Clinical/Medical	Rheumatoid Arthritis: Developing Drug Products for Treatment (PDF - 176KB)	Draft Guidance	05/30/13
Current Good Manufacturing Practices (CGMPs)/Compliance	Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 86KB)	Draft Guidance	05/24/13
International Conference on Harmonisation - Quality	Annex 13 Bulk Density and Tapped Density of Powders General Chapter	Final Guidance	05/24/13
Drug Safety	Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets (PDF - 501KB)	Final Guidance	05/14/13
Procedural	Charging for Investigational Drugs Under an IND — Qs & As (PDF - 57KB)	Draft Guidance	05/08/13
Procedural	Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF - 75KB)	Draft Guidance	05/08/13
Chemisty; Manufacturing and Controls (CMC)	Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 84KB)	Final Guidance	04/25/13
Drug Safety	Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (PDF - 608KB)	Draft Guidance	04/23/13
Current Good Manufacturing Practices (CGMPs)	Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 70KB)	Final Guidance	04/17/13
International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)	M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (PDF - 426KB)	Draft Guidance	04/12/13
Over-the-Counter	Self-Selection Studies for Nonprescription Drug Products (PDF - 160KB)	Final Guidance	04/10/13
Drug Safety	Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF - 183KB)	Draft Guidance	04/05/13
Draft Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4	Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 - Draft Guidance for Industry and FDA Staff (PDF - 98KB)		04/01/13
Chemistry, Manufacturing and Controls. (CMC)	SUPAC: Manufacturing Equipment Addendum (PDF - 321KB)	Draft Guidance	04/01/13
Biosimilarity; Procedural	Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF - 272KB)	Draft Guidance	03/29/13
Chemistry, Manufacturing, and Controls (CMC)	Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation (PDF - 56KB)	Final Guidance	03/13/13
Procedural	Formal Dispute Resolution: Appeals Above the Division Level _Draft (PDF - 241KB)	Draft Guidance	03/12/13