FDA Related News

Human Drugs

CGMP Violations at Natural Beauty Care

FDA warns Australias Natural Beauty of CGMP issues in its production of OTC drugs.

Biologics

Moderna Seeks Full Licensure for Covid Vaccine

Moderna completes a rolling BLA and requests a priority review for the submission seeking full licensure of its Covid-19 vaccine.

Federal Register

Info Collection on Data Monitoring Committees

Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment and Operation of Clinical Trial Data Monitoring C...

Federal Register

Vaccines Advisory Committee Meeting 9/30

Federal Register notice: FDA announces a 9/30 Vaccines and Related Biological Products Advisory Committee meeting.

Medical Devices

Class 1 Recall of Alaris Infusion Pump Bezel Assembly

FDA classifies as Class 1 a Bio-Medical Equipment Service Co. recall of the Alaris Infusion Pump Module Model 8100 pump bezel assembly and Alaris infu...

PhRMA Updates Healthcare Professional Interaction Code

Two Hyman, Phelps & McNamara attorneys describe updates to the PhRMA Code on Interactions with Healthcare Professionals dealing with speaker programs.

Medical Devices

Medtronics Evolut FX TAVR System Approved

FDA approves a Medtronic PMA for its Evolut FX TAVR system for treating severe aortic stenosis patients.

Human Drugs

FDA Warns Mahita on Unapproved Covid Products

FDA sends a Warning Letter to Mahita, LLC (Suwanee, GA) after determining that the firm was marketing unapproved and misbranded products related to Co...

Medical Devices

Siemens De Novo Granted for Liver Fibrosis Test

FDA grants a de novo authorization to Siemens Healthineers for its Enhanced Liver Fibrosis Test and its use with the Advia Centaur XP Immunoassay Syst...

Human Drugs

FDA Aurobindo Pharma Inspection Has 7 Observations

FDA releases an FDA-483 with seven observations from an inspection at Indias Aurobindo Pharma Unit 1.