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Biologics

FDA Orders GREFI to Stop Making Cell/Tissue Products

FDA orders Gynecology, Reproductive Endocrinology and Fertility Institute to immediately stop manufacturing cell/tissue products after an October insp...

Medical Devices

Workshop on Artificial Intelligence in Radiological Imaging

FDA announces a 2/25 public workshop entitled Evolving Role of Artificial Intelligence in Radiological Imaging.

Federal Register

Review Period for Novo Nordisks Ozempic

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Ozempic.

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 11/29/2019.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Tzvi Lexiere Debarred for 10 Years

Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle ...

Federal Register

Six ANDAs Withdrawn by FDA

FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed.

Federal Register

Draft Guide on Biosimilar Clinical Immunogenicity

Federal Register notice: FDA makes available a draft guidance entitled Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insul...

Medical Devices

FDA Approves QuantiFeron-TB Plus Diagnostic

FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tuberculosis detection.

Medical Devices

Zebra Medical 510(k) Cleared for HealthCXR

FDA clears a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in Chest X-rays.