FDA Related News

Medical Devices

Boston Scientific Recalls Imager Angiographic Catheters

Boston Scientific recalls its Imager II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patien...

Views on Biosimilar Competitive Marketplace

Two stakeholders comment on an FDA/FTC public workshop on a biosimilars competitive marketplace.

Medical Devices

FDA Clears Nitiloop NovaCross Microcatheter

FDA clears a Nitiloop 510(k) for its NovaCross CTO Microcatheter and its use in intraluminal placement of conventional and steerable guidewires beyond...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Global Treat Srl, Mandelay Kft and Philip Kennedy.

Federal Register

Notice Corrected on ANDA Approval Withdrawals

Federal Register notice: FDA corrects a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs.

Federal Register

User Fee Report on Drug/Biosimilar Review Resources

Federal Register notice: FDA posts a user fee-related report providing options and recommendations for a new methodology to assess changes in the reso...

Federal Register

Panel Review of GSK Trelegy Ellipta sNDA Postponed

Federal Register notice: FDA postpones a 4/21-planned Pulmonary-Allergy Drugs Advisory Committee meeting that was scheduled to discuss a GlaxoSmithKli...

Human Drugs

CGMP Violations at Global Treat

FDA warns Romanias Global Treat Srl about CGMP violations in its production of finished drugs.

Human Drugs

Stakeholders Comment on Biosimilars Labeling Guidance

Three stakeholders tell what they like about an FDA draft guidance on biosimilar promotional advertising and labeling.

Medical Devices

FDA Backing Off Some Ophthalmic Device Enforcement

FDA says it will exercise enforcement discretion for some ophthalmic assessment and monitoring devices during the coronavirus pandemic.