FDA Related News

FDA General

Six Former FDA Heads Urge Biden to Pick Commissioner

Six former FDA commissioners urge President Biden to prioritize the nomination and confirmation of an FDA commissioner.

Human Drugs

Idorsia NDA for Insomnia Drug

FDA begins reviewing an Idorsia NDA for its investigational daridorexant for treating adult patients with insomnia.

Medical Devices

Former FDA Lawyer Heading TSG Medical Device Practice

TSG Consulting hires former FDA lawyer Laurie Clarke to lead its medical device regulatory practice.

Pfizer Vaccine Plant Has Troubled Compliance History: Report

Kaiser Health News reports that the Pfizer McPherson, KS, sterile drug facility that is slated to start producing Covid-19 vaccine has a troubled regu...

Human Drugs

Vertex Gets Fast Track for Diabetes Cell Therapy

FDA grants Vertex Pharmaceuticals a fast track designation for VX-880 for treating patients who have Type 1 diabetes with severe hypoglycemia and impa...

Human Drugs

Bryant Ranch Recalls Mislabeled Spironolactone

Bryant Ranch Prepack recalls four lots of spironolactone tablets after determining they have been mislabeled and display the incorrect strength.

Human Drugs

Lannett Incorporating FDA Biosimilar Insulin Product Feedback

Lannett says it is incorporating FDA recommendations into a pivotal trial for its biosimilar insulin glargine product that is under development.

Human Drugs

PDSA Joins Opposition to Florida Drug Importation Program

The Pharmaceutical Distribution Security Alliance calls on FDA not to authorize Floridas proposal to import drugs from Canada, saying it would be ille...

Medical Devices

FDA and Medical Device Regulations in 2021: Analysis

Attorney Jim Shehan outlines possible FDA 2021 activities involving medical devices.

Medical Devices

Akesis Galaxy RTi Radiosurgery Device Cleared

FDA clears an Akesis 510(k) for the Akesis Galaxy RTi, an advanced gamma stereotactic radiosurgery system with continuous 360-degree rotational techno...