Melissa Gilmore

FDA Finalizes Rule On Unique Device Identification System

Bicameral, Bipartisan Compounding Pharmacy Legislation Finally Announced

FDA Issues Much-Anticipated New Guidance On Wireless Medical Devices

FDA: New User Fees Begin Oct. 1, 2013, Increases Up to 10%

FDA Drug Import Rules Up For Public Comment

GAO Recommends Congress Clarify FDA’s Authority To Oversee Drug Compounding

New FDA Guidance On Medical Devices: Enhanced Reporting Requirements For Adverse Events

Compounding Animal Drugs From Bulk Ingredients: Not Prohibited By Federal Food Drug And Cosmetic Act, Affirmed As Recently As 2011

Medical Device Industry Concerned Over Proposed Overseas Clinical Trial Rule

New FDA Guidance On Appeals Processes For Medical Device Denials