FDA Related News

10-Year History of Sentinel System

FDA and Harvard Medical School staff discuss the history and use of the agencys Sentinel medical product safety system.

Human Drugs

ActiveHerb Marketing Unapproved, Misbranded Drugs: FDA

FDA warns ActiveHerb Technology about multiple violations in its manufacture and sale of unapproved and misbranded new drugs.

Medical Devices

FDA Clears Misonix 510(k) for Nexus

FDA clears a Misonix 510(k) for Nexus, an ultrasonic surgical platform.

FDA General

House Committee Moves FDA $184 Budget Boost Forward

The House Appropriations Committee marks up and passes the fiscal year 2020 Agriculture/FDA appropriations bill that would provide the agency with an ...

Human Drugs

Biosimilar, Interchangeable Pathway Working Well: BI

Boehringer Ingelheim expresses general support for an FDA final guidance on considerations in demonstrating interchangeability with a reference produc...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes ActiveHerb Technology and Kingston Pharma.

Federal Register

Info Collection on Tobacco Product Guidance

Federal Register notice: FDA submits to OMB an information collection extension for Guidance for Industry on Establishing That a Tobacco Product Was C...

Human Drugs

BLA Accepted for Celgene/Accelerons Luspatercept

FDA accepts for review a Celgene and Acceleron BLA for luspatercept for treating certain patients with very low to intermediate-risk myelodysplastic s...

Medical Devices

FDA Approves TransMedics Organ Care System Lung

FDA approves a TransMedics Group PMA for expanded clinical indications of the Organ Care System Lung to be used for the preservation and ex-vivo asses...

Human Drugs

Merck Wins New Indication for Zerbaxa

FDA approves a Merck NDA for a new indication for Zerbaxa (ceftolozane and tazobactam) for treating hospital-acquired bacterial pneumonia and ventilat...