FDA Related News

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Praise for FDA Bayesian Methodology Draft Guidance

Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the draft.

FDA Draft Guidance on Responses to FDA-483s Explained

Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-48...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

Human Drugs

FDA Extends Review of Lantheus PET Imaging Agent

FDA extends by three months its review of a Lantheus Holdings NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocrine tumors.

FDA General

Senators Demand HHS Reverse Autism-Related Web Site Changes

A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccine...

Human Drugs

FDA Flags Sterility, Contamination Control Issues at India Plant

FDA inspectors cite multiple manufacturing and quality control deficiencies at a Gland Chemicals Private Limited in Chennai, India, manufacturing faci...

FDA General

FDA Updates Internal Procedures for Handling Supplements

FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.