FDA Related News

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Praise for FDA Bayesian Methodology Draft Guidance

Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the draft.

FDA Draft Guidance on Responses to FDA-483s Explained

Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-48...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

Human Drugs

FDA Will Review Ketamine-Based Drug Without New Trials: NRx

NRx Pharmaceuticals says FDA has indicated it is willing to review a potential NDA for its investigational therapy NRX-100 without requiring additiona...

Human Drugs

NovaBridge Says FDA Open to Accelerated Approval for Givastomig

FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approval pathway following...

Human Drugs

FDA Accepts Sun Pharma Filing to Expand Ilumya Use

FDA accepts for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) to treat adults with ...