FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

FDA Will Review Pfizer Etrasimod NDA

FDA accepts for review a Pfizer NDA for etrasimod to treat some patients with ulcerative colitis.

Human Drugs

Celltrion Submits BLA for Novel Infliximab Formula

Celltrion USA submits a BLA to FDA for a novel subcutaneous formulation of its infliximab to be used as maintenance therapy in some ulcerative colitis...

latest-news-card-1
Human Drugs

Academics Urge Tougher FDA Stance on Accelerated NDAs

Two JAMA articles say FDA should seek to tweak its accelerated approval program to make it easier for it to pull an approval if a confirmatory study d...

Federal Register

Device Voluntary Malfunction Summary Reporting Guide

Federal Register notice: FDA is releases a draft guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.

latest-news-card-1
Federal Register

Guide on Device Human Factors Submission Info

Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Submissions.

latest-news-card-1
Federal Register

Proposal to Exempt Dietary Supplements in Some Drug Studies

Federal Register proposed rule: FDA proposes to amend its regulations on INDs to exempt certain clinical investigations of lawfully marketed foods for...

latest-news-card-1
Federal Register

Proposal to Replace IND Annual Reporting Requirement

Federal Register proposed rule: FDA proposes to replace its current annual reporting requirement for INDs with a new requirement: the annual FDA devel...

latest-news-card-1
Medical Devices

Remel Recalls Thermo Scientific Sensititre Plates

Remel recalls Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe.

latest-news-card-1
Biologics

Janssen Files BLA for Myeloma Therapy

Janssen Pharmaceutical files a BLA for talquetamab for treating patients with relapsed or refractory multiple myeloma.

latest-news-card-1
Human Drugs

2 Roche Alzheimers Tests Cleared by FDA

FDA grants Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) Alzheimers Disease...