FDA Related News

Human Drugs

Multiple Violations at Fusion IV Pharmaceuticals

FDA warns Fusion IV Pharmaceuticals about multiple violations in its production of compounded drugs as an outsourcing facility.

Justice Department FCA Memos Explained

Attorneys appearing on a Washington Legal Foundation webinar discuss two Justice Department memos that bear on False Claims Act cases.

FDA General

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes one medical product maker Fusion IV Pharmaceuticals.

Medical Devices

Med-El Hearing Patch Cleared by FDA

FDA clears a Med-El USA 510(k) for its next generation non-surgical bone conduction hearing technology called AdHear.

Human Drugs

Statistical Principles Addendum Issues Raised

PhRMA and AstraZeneca give FDA five points to clarify in an addendum to a draft International Conference on Harmonization guidance on clinical trial s...

Human Drugs

Actelion Files sNDA for Opsumit

Actelion Pharmaceuticals files a supplemental NDA to expand the indication for Opsumit (macitentan) to include treating adults with inoperable chronic...

Medical Devices

Medtronic's Infuse Approved for Expanded Uses

FDA approves Medtronics Infuse Bone Graft in new spine surgery indications.

Medical Devices

Significant Changes Seen in NGS Guidance: Attorney

Attorney Allyson Mullen says FDA made significant changes to a finalized guidance on using IVDs to aid in diagnosing germline diseases.

Human Drugs

Many eCTD Files Due 5/5

FDA reminds drug sponsors of eCTD compliance dates for drug master files and other documents.

Human Drugs

CDER Ombudsman Total Contacts Down

The CDER Ombudsman reports a 28% drop in contacts from 2016 to 2017.