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Human Drugs

BMS Recalls 1 Lot of Mislabeled Eliquis

Bristol-Myers Squibb recalls one lot of its blood thinner Eliquis (apixaban) 5 mg tablets after a customer complaint said a bottle labeled as Eliquis ...

Medical Devices

Etiometry Gains Expanded Clearance for Oxygen Patient Monitor

FDA clears an Etiometry 510(k) for the Inadequate Oxygen Delivery Index for monitoring intensive care unit patients aged 12 years or younger.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes A-S Medication Solutions, Belmora and The See Clear Company.

Human Drugs

BI Wants COPD Triple-Combination Restrictions

Boehringer Ingelheim asks FDA not to approve NDAs for a fixed-dose, triple-combination, inhaled drug product to treat COPD unless the product meets Co...

Medical Devices

FDA Clears I-Bones iFuse 3D Implant

FDA clears an I-Bone 510(k) for the iFuse-3D Implant, the first-ever 3D-printed titanium implant for use in the sacroiliac joint.

Medical Devices

FDA Clears Techlab Test for Intestinal Parasite

FDA clears a Techlab 510(k) for its E. Histolytica Quik Chek, a rapid diagnostic test for detecting pathogenic E. histolytica that does not cross reac...

Human Drugs

FDA Clears GenMark ePlex/Respiratory Panel

FDA clears a GenMark Diagnostics 510(k) for both its ePlex instrument and Respiratory Pathogen Panel.

Biologics

Supreme Court Ruling to Allow Biosimilars on Market Sooner

A U.S. Supreme Court ruling means biosimilar products are likely to launch faster due to an earlier marketing advance notice option.

Federal Register

Comments Sought on New DTC Survey on Adequate Provision

Federal Register notice: FDA seeks comments on a proposed information collection involving new research entitled Utilization of Adequate Provision amo...

Human Drugs

FDA Rejects Coherus Bios Proposed Neulasta Biosimilar

FDA issues Coherus BioSciences a complete response letter on its BLA for a biosimilar copy of Amgens Neulasta (pegfilgrastim), indicated for reducing ...