FDA Related News

FDA Denies Petition on Eugia Pharma ANDA

FDA denies a petition questioning Eugia Pharmas use of an ANDA for a generic Makena autoinjector.

Human Drugs

Improve Cancer Checkpoint Inhibitor Development: Pazdur

Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver call for changes in the development process for new c...

Human Drugs

FTC Should Look Into Par Vasostrict Petition: FDA

FDA denies a Par Sterile Products petition saying it failed to raise valid scientific or regulatory issues and was submitted as a delaying tactic.

Human Drugs

Guide on Inspecting Injectables for Particulates

FDA posts a draft guidance entitled Inspection of Injectable Products for Visible Particulates.

Medical Devices

Proposed Rule on QSR Harmonization Soon: Maisel

CDRH Office of Product Evaluation and Quality director William H. Maisel tells an industry conference that the agency is planning to release very soon...

Biologics

FDA Revises Janssen Covid Vaccine Fact Sheets

FDA says fact sheets for the Janssen Covid-19 vaccine have been updated with a Contraindication for the vaccine in individuals with a history of throm...

Medical Devices

Device Definition Draft Guidance

FDA issues a draft guidance on the redesignation of the definition of device in the Federal Food, Drug, and Cosmetic Act and the addition of a definit...

Federal Register

Abdominal Pain Nerve Stimulator is Class 2

Federal Register notice: FDA classifies the nonimplanted nerve stimulator for functional abdominal pain relief into Class 2 (special controls).

Federal Register

Endoscopic Transhepatic Venous Needle is Class 2

Federal Register notice: FDA classifies the endoscopic transhepatic venous access needle into Class 2 (special controls).

Federal Register

FDA Proposes PMAs for Spinal Spheres

Federal Register notice: FDA proposes to require PMAs for spinal spheres for use in intervertebral fusion procedures.