FDA Related News

Human Drugs

FDA Extends Review of TG Therapeutics Submissions

FDA extends by three months its review of a TG Therapeutics BLA and supplemental NDA for ublituximab in combination with Ukoniq (umbralisib), indicate...

Human Drugs

Median Seeks FDA Input on iBiopsy Regulatory Pathway

Median Technologies files a 513(g) submission seeking FDA guidance on the best path to market for its iBiopsy Lung Cancer Screening Artificial Intelli...

Medical Devices

Circa Scientific Esophageal Temperature Probe Cleared

FDA clears a Circa Scientific 510(k) for its S-CATH M Esophageal Temperature Probe which can be visualized on 3D cardiac mapping systems.

Human Drugs

Civica Planning for Affordable Insulins

Civica says it will develop and manufacture three insulin biosimilars to be sold at a lower price than current products.

Federal Register

Navarro Debarred Over Study Fabrications

Federal Register notice: FDA permanently debars Eduardo Navarro from providing services related to an approved or pending drug product application.

Federal Register

4 Information Collections Approved by OMB

Federal Register notice: FDA posts four recent information collections that have been approved by OMB.

Recall Ready Guidance Out

FDA publishes a guidance to help companies be ready to quickly and effectively remove recalled products from the market.

Human Drugs

Questions Raised Again About Accelerated Approvals

The Los Angeles Times raises concerns about FDAs use of accelerated approval pathways for many new drugs.

Device, Drug Recalls Down in 2021: Sedgwick

The Sedgwick recall index for 2021 shows that both medical devices and drugs had fewer recalls and the recalls involved more units.

Human Drugs

FDA 2021 Personalized Medicine Milestones

The Personalized Medicine Coalition says FDA is accelerating its involvement in personalized medicine.