FDA Related News

Human Drugs

Paxlovid Widely Available in Pharmacies: Farley

CDER Office of Infectious Diseases director John Farley answers healthcare provider questions about using Pfizers Paxlovid on authorized Covid-19 pati...

Medical Devices

FDA OKs Marketing of New Alzheimers Diagnostic

FDA permits marketing of a Fujirebio in vitro diagnostic test for Alzheimers disease.

Marketing

Additional FDA Native Advertising Enforcement Likely: Attorney

Attorney Dara Levy predicts increased FDA enforcement involving so-called native advertising and other new promotional trends.

Human Drugs

ICH Model-Informed Drug Development Roadmap

The International Council on Harmonization publishes its Model-Informed Drug Development Discussion Group roadmap for future guidelines.

FDA General

User Fee Bill Looks to Improve Accelerated Approval, Inspections

The House Energy and Commerce Committee releases a comprehensive legislative package to reauthorize FDA user fee agreements and enhance accelerated ap...

Medical Devices

Revised Guide on PMA/HDE Supplements During Covid

FDA posts a revised final guidance entitled Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions Durin...

Human Drugs

Senators Want Opioid Label Changes

Sens. Hassan and Braun call on FDA commissioner Robert Califf to quickly lead a revision of opioid drug labeling.

Human Drugs

FDA Lifts Hold on Pfizer Hemophilia A Gene Therapy

FDA removes a clinical hold on Pfizers giroctocogene fitelparvovec (Hemophilia A gene therapy); the company plans to resume dosing in its AFFINE trial...

Medical Devices

FDA Proposes 2nd Section 518(b) Order for Philips

FDA proposes issuing a second Section 518(b) order against Philips Respironics, this time to require the company to submit a plan to repair, replace, ...

Confusion Over RWD and RWE: Perspective

Two CDER executives discuss misconceptions that remain about the meaning and use of real-world data and real-world evidence.