CDER News

Guidance for Industry

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

Guidance for Industry

Q10 Pharmaceutical Quality System

Adverse Event Reporting System (AERS) Statistics (updated)

Manual of Policies and Procedures (MaPP)

Productivity Documentation in the Division of Bioequivalence

Guidance for Industry

Comprehensive List of Guidance Documents

Guidance for Industry

New Revised/Withdrawn List for 2009

FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs

The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

Manual of Policies and Procedures (MaPP)

Joint Safety Meetings Between OND and OSE

Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry

Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009

Generic Drug Petition Tracking: Suitability Tracking Reports

Pharma Company Jobs