FDA – Page 2 – Policy & Medicine

FDA Seeks Comments on Transparency and Communication for New Entities

The Food and Drug Administration Safety and Innovation Act (FDASIA): Summary of GDUFA, MDUFA, BsUFA and Pediatrics

FDA: Recently Signed PDUFA 5 Provisions to Address Drug Shortages

FDA: Food and Drug Administration Safety and Innovation Act (FDASIA) and Patient Focused Drug Development

FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for Extended Release/Long Acting Opioids Including a Prescriber Education Program

FDA REMS: Blue Print for Prescriber Continuing Education Program for Extended Release-Long Acting Opioids

The Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011: House Introduces Bill to Relieve FDA of Burdensome Conflict of Interest Quotas

Par Pharmaceuticals vs. FDA Calling for Truthful Speech vs. FDA Approved

FDA Updates 510K Approval Process for Medical Devices

Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices or The Rothman’s Efforts to Undermine Public Health