FDA Related News

Human Drugs

OPDP Hits AbbVie Over Serena Williams DTC Ad

CDERs Office of Prescription Drug Promotion cites AbbVie in a just-released untitled letter over its television direct-to-consumer advertisement for m...

Human Drugs

3 FDA Innovative Manufacturing Action Steps

FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.

Medical Devices

FDA Warns 2 Chinese Labs About Data Concerns

FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.

Human Drugs

Lawsuit Against FDA Dismissed on Ripeness Grounds

The Washington, DC District Court dismisses a Vanda Pharmaceuticals lawsuit against FDA that challenged the agencys bioequivalence determination of a ...

Human Drugs

Ocaliva Confirmatory Trial Fails: FDA

FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocaliva to treat some cas...

Biologics

GSK Nixes Herpes Simplex Virus Vaccine

GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recent Phase 1-2 study.

Medical Devices

Hinge Health Wireless Pain Device Cleared

FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.

Human Drugs

CDER Quantitative Medicine CoE Explained

CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and regulatory review.

Follow FDA Online Misinformation Guidance: Attorneys

Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformation carried on the I...

Medical Devices

DeepWell Digital Software Cleared for Stress Relief

FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments to relieve stres...