FDA – Page 58 – Policy & Medicine

FDA CDRH – MDUFA Agreement and Strategic Priorities for 2012

FDA Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review

FDA Submits to Congress User Fee Act Recommendations

FDA: Transmucosal Immediate-release Fentanyl (TIRF) REMS

FDA Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

FDA Guidance Responding to Unsolicited Request for Off-Label Information About Prescription Drugs and Medical Devices

FDA the Headache of Developing a Biosimilar Pathway

CMS-FDA Breast Cancer and Avastin: FDA Pulls Approval While CMS Pays

Policy Updates and Enforcement Developments from FDA’s Medical Products Centers: Tips on Social Media

In Advance of PDUFA FDA on Record Approval Pace