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FDA Portal for Annual Drug Manufacturing Reporting

[ Price : $8.95]

FDA announces the availability of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biol...

Zimmer Biomet Recalls Rosa One Brain App

[ Price : $8.95]

Zimmer Biomet recalls its Rosa One 3.1 Brain Application, a robotic platform that helps neurosurgeons with positioning medical ins...

FDA Listing on Device EUAs During Covid

[ Price : $8.95]

Federal Register notice: FDA announces a periodic listing of Emergency Use Authorizations for certain medical devices related to t...

4 Information Collections Approved by OMB

[ Price : $8.95]

Federal Register notice: FDA posts a list of information collections that have been approved by OMB.

Enzyvant Wins Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified ...

HHS, Purdue Differ on Buprenorphine

[ Price : $8.95]

As HHS suggests increasing access to buprenorphine to treat opioid addiction, manufacturer Purdue Pharma emphasizes its addiction ...

OPDP to Study Targeted Mechanism of Action in Ads

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion says it will study how consumers and healthcare professionals react to promotional ...

Millions of J&J Covid Doses in Storage: Report

[ Price : $8.95]

Millions of J&J Covid vaccine doses are reported to be sitting in the Emergent facility in Baltimore waiting for FDA to authorize ...

NeuroLogica AI Lung Nodule Detector Cleared

[ Price : $8.95]

FDA clears a NeuroLogica 510(k) for its Auto Lung Nodule Detection (ALND) tool, a computer-assisted detection device for detecting...

Life Tech Covid Tests EUA Revoked

[ Price : $8.95]

Federal Register notice: FDA announces the revocation of the Emergency Use Authorization issued to Life Technologies Corporation f...