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Human Drugs

FDA Targets Global Web Sites for Illegal Drugs

FDA says that during the recent International Internet Week of Action it targeted 465 Web sites that illegally sold potentially dangerous, unapproved ...

FDA General

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes one medical product company Auro Pharmacies.

Medical Devices

Safety Alert on Raindrop Near Vision Inlay

A new safety alert warns against an increased risk of corneal haze associated with Optics Medicals Raindrop Near Vision Inlay.

Human Drugs

Review Extended for sBLA for Opdivo/Yervoy

FDA extends by three months its review of a Bristol-Myers Squibb supplemental BLA for an indication in metastatic first-line non-small cell lung cance...

Federal Register

Allergenic Products Advisory Panel Meeting Canceled

Federal Register notice: FDA cancels an 11/7 Allergenic Products Advisory Committee meeting that was scheduled to discuss the use of challenge studies...

Federal Register

Modified Publication for Device Consensus Standards

Federal Register notice: FDA makes available a publication containing modifications to the list of standards it recognizes for use in premarket review...

Federal Register

Approval Withdrawn for 20 NDAs

Federal Register notice: FDA withdraws the approval of 20 NDAs from multiple applicants after they notified the agency that the drug products were no ...

Federal Register

Regulatory Review Period Determined for Imfinzi

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for MedImmunes Imfinzi (durvalumab), indica...

FDA General

Former FDA Associate Chief Counsel Joins Ropes & Gray

Former FDA Associate Chief Counsel for Enforcement Beth Weinman joins Ropes & Gray at its Washington, D.C. office as counsel in the firms life science...

Medical Devices

510(k) Pilot for Optical Coherence Tomography Devices

FDA announces a voluntary Optical Coherence Tomography Premarket Notification (510(k)) Pilot Program, which is intended to develop and refine individu...