FDA Related News

Human Drugs

Draft Guide on Chemo-induced Nausea Drugs

Federal Register notice: FDA makes available a draft guidance entitled Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.

Biologics

Iovance Delays Lifileucel BLA on FDA Feedback

Iovance Biotherapeutics says FDA regulatory feedback on potency assays for lifileucel will delay a planned BLA for the therapy.

Surge in Product Recalls Predicted

International business management consultancy Sedgwick says drug and medical device product recalls are likely to surge as companies return to busines...

Medical Devices

Congress Should Ensure FDA Test Review Authority: Pew

The Pew Trusts calls for legislative action to maintain FDA authority over laboratory-developed tests.

Federal Register

2 Verapamil Drugs Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Adams Technologies Isoptin (verapamil hydrochloride) tablets (40mg, 80mg and 120mg) and Pfizers Calan (ve...

Human Drugs

Woodcocks Ideas to Strengthen Clinical Trials

FDA acting commissioner Janet Woodcock suggests changes to the nations clinical trial system in response to pandemic lessons learned.

Human Drugs

Bio-Botanica/Natures Answer Cesium Chloride Product Adulterated: FDA

FDA warns Bio-Botanica/Natures Answer that it is marketing adulterated Coral Calcium because it contains cesium chloride, an unapproved new dietary in...

Human Drugs

Covid Trial Impact Less in Oncology: Study

Researchers say oncology trials were not affected by the pandemic as much as non-oncology trials.

Federal Register

5 FDA Information Collections Approved by OMB

Federal Register notice: FDA posts a list of five information collections that have been approved by the Office of Management and Budget.

Human Drugs

FDA Says NeuroHydrate Selling Unapproved New Drug

FDA warns NeuroHydrate that it is marketing an unapproved new drug.