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Federal Register

8 Information Collections Approved by OMB

Federal Register notice: FDA announces that eight information collections have recently been approved by OMB.

Medical Devices

Neurological Devices Panel Meeting Summary

FDA releases a summary of the Neurological Devices Panel discussion on the classification of six unclassified, preamendments medical devices.

Human Drugs

Vertex Pharma Gains Expanded Trikafta Approval

FDA approves a Vertex Pharmaceuticals supplemental NDA for Trikafta (elexacaftor/tezacaftor/ivacaftor) to include certain children with cystic fibrosi...

Human Drugs

Steps to Strengthen Drug Supply Chain

FDA and HHS release a report with recommendations for strengthening the nations pharmaceutical supply chain.

Human Drugs

2 Guilty of Falsifying Drug Trial Data

Two Tellus Clinical Research clinical trial staff plead guilty to charges they falsified trial data.

FDA General

Continue, Enhance Operational Technology Security: FDA

FDA says two government agencies should enhance their efforts in the area of operational technology cybersecurity.

Biologics

Pfizers Prevnar 20 Pneumococcal Vaccine Approved

FDA approves Pfizers Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by 20 Streptococcus pn...

Medical Devices

CyMedica Orthos Knee Pain Neuromodulator Cleared

FDA clears a CyMedica Orthopedics 510(k) for its IntelliHab for managing knee osteoarthritis pain.

Human Drugs

Everything Health Selling Illegal Covid Products: FDA

FDA warns Everything Health that its Web site and social media pages are selling unapproved and misbranded new drugs purporting to treat Covid-19.

Human Drugs

RVL Pharmaceuticals Wants Upneeq Equivalence Requirements

RVL Pharmaceuticals asks FDA to take six specific actions for any ANDA or 505(b)(2) application referencing its Upneeq.