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Federal Register

Regulatory Review Determined for Jardiance

Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Boehringer Ingelheims Jardiance (empaglifl...

Human Drugs

Verubescesat Unlikely to Succeed in Alzheimers: Merck

Merck ends a Phase 3 study of verubescesat in Alzheimers disease patients.

Human Drugs

NIH Respiratory Tract Marker Study

The National Institute of Allergy and Infectious Diseases says it is studying whether blood levels of procalcitonin can predict whether a lower respir...

Human Drugs

CGMP Issues at Bayer Leverkusen

FDA warns Bayer Pharma about CGMP inspection violations at its drug manufacturing facility in Leverkusen, Germany.

Medical Devices

QS, MDR Issues at Curasan AG

FDA warns Germanys Curasan AG about Quality System and Medical Device Reporting regulation violations in its production of several dental devices.

Federal Register

Vaccines Advisory Panel to Meet 3/1

Federal Register notice: FDA announces a 3/1 Vaccines and Related Biological Products Advisory Committee meeting.

Federal Register

Workshop on Orthopedic SMART Devices

Federal Register notice: FDA announces a 4/30 public workshop entitled Orthopedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Device...

Federal Register

Neurological Devices Panel Meeting Amended

Federal Register notice: FDA amends a notice about a 3/1 Neurological Devices Panel of the Medical Devices Advisory Committee meeting to reflect a cha...

Federal Register

CDER Rejects NDA for Oxycodone HCL; Hearing Offered

Federal Register notice: CDER proposes to refuse approval of a Pharmaceutical Manufacturing Research Services NDA for oxycodone hydrochloride immediat...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Bayer AG, Cosmecca Korea Co., Curasan AG, Guangzhou Baiyunshan Pharmaceutical Holdings ...