FDA Related News

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.

Human Drugs

FDA Approves Expanded Xarelto Indication

FDA approves an expanded indication for Janssens Xarelto to include patients with recent lower extremity revascularization under specific circumstance...

Human Drugs

7 Observations in Jubilant Generics FDA-483

FDA released the FDA-483 with seven observations from an inspection at Indias Jubilant Generics drug manufacturing firm.

Human Drugs

FDAers Boost Viral Clearance in Continuous Manufacturing

FDA says CDER researchers have developed a three-step process to promote viral clearance during continuous manufacturing of therapeutic proteins.

Human Drugs

Senators Want Info on FDA Relationship with McKinsey in Opioid Crisis

A bipartisan group of six senators quizzes FDA on the potential conflicts of interest in agency contracts with McKinsey since the consulting firm also...

Human Drugs

CGMP Violation Found in Toyobo Inspection

FDA warns Japans Toyobo Co. about a CGMP violation in its manufacturing of finished drugs.