FDA Related News

Human Drugs

FDA Infectious Disease Designation for Acurx Antibiotic

FDA designates Acurx Pharmaceuticals lead antibiotic product candidate, ACX-362E, as a qualified infectious disease product.

Federal Register

FDA Withdraws Approval of 5 NDAs

Federal Register notice: FDA has withdrawn the approval of five NDAs from multiple applicants.

Medical Devices

FDA Clears TransMed7 SpeedBird Biopsy Platform

FDA clears a TransMed7 510(k) for the SpeedBird platform of soft tissue biopsy devices.

Human Drugs

FDA Redesigns Drug Shortage Web Page

FDA redesigns its drug shortage Web page to make it easier to quickly locate current shortage information.

Human Drugs

Depressive Disorder Drug Development Guidance

FDA releases a draft guidance to help sponsors with clinical development of drugs to treat major depressive disorder.

Inhaler Quality Consideration Issues Raised

Four stakeholders raise concerns with an FDA docket and draft guidance on quality considerations for metered dose and dry powder inhalers.

Human Drugs

Right-to-Try Could Upset Access/Safety Balance: Study

Yale University researchers caution that right-to-try laws can upset the balance between access and safety FDA has reached with drug manufacturers in ...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Biologique Recherche and Oeyama-Moto Medical Group Foundation.

Human Drugs

New Generic Drug Development Initiatives

FDA commissioner Scott Gottlieb describes two new initiatives he wants to have funding in the agencys next budget to further promote generic drug deve...

Human Drugs

CGMP Violations at Frances Biologique Recherche

FDA warns Frances Biologique Recheche about CGMP violations in its production of finished drugs.