FDA Related News

FDA General

FDA Updates Guidance on Pyrogen and Endotoxin Testing

FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater...

Medical Devices

FDA Warns of Potentially High-Risk Issue With Insulet Insulin Pumps

FDA issues an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet.

Human Drugs

Oralabs Cited for CGMP Violations

FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.

Human Drugs

API Deviations Seen in Flowchem Pharma Inspection

FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.

Human Drugs

BioMarin Halts Dosing in Some Voxzogo Mid-Stage Trials

BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare...

Medical Devices

Integra Neurosurgical Kits Recalled Over Corrosion Risk

Integra LifeSciences recalls certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component used during procedures ...

Human Drugs

Quality Control, Microbial Risks Flagged at API Manufacturer

FDA sends Japanese active pharmaceutical ingredient maker Alps Pharmaceutical a Form 483 from an inspection that identified multiple manufacturing and...

Human Drugs

Praise for FDA Bayesian Methodology Draft Guidance

Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the draft.

FDA Draft Guidance on Responses to FDA-483s Explained

Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-48...

Human Drugs

FDA Rejects Aldeyras Dry Eye Drug Reproxalap

FDA sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company failed to provide suffi...