FDA – Page 60 – Policy & Medicine

FDA “Consumer Groups” Sidestep PDUFA Meetings

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

Medical Device Regulatory Improvement Act Introduced: Senators Call for Reducing Arbitrary Conflict of Interest Quotas on FDA Panels

FDA Guidance on Informed Consent

FDA Biosimilars Guidance Coming Soon

FDA Draft Guidance – Oversight of Clinical Investigations: A Risk Based Approach to Monitoring

FDA Revises Guidance on Marketed Unapproved Drugs – Enforcement Actions without Notice

Study Shows Adherence to FDA Advertising Guidelines Are in the Eye of the Beholder

ACRE Releases Statement on Enhancing FDA Advisory Committee Recruitment

Drug Shortages Potential Causes Stricter FDA, Price Controls and Policies Against Newer Medications