FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Federal Register

Info Collection on Kratom Research Study

Federal Register notice: FDA seeks comments on a proposed information collection entitled Risk/Safety Considerations and Motivations for Purchase and ...

latest-news-card-1
Human Drugs

Updated CDER Guidance Agenda

CDER posts an updated 2024 guidance agenda listing 101 guidances in 17 categories.

latest-news-card-1
Human Drugs

M12 Drug Interaction Q&A

FDA publishes an International Council on Harmonization Question and Answer guidance to clarify its M12 guidance on drug interaction studies.

latest-news-card-1
Human Drugs

Durbin, Cassidy Introduce Drug Competition Bill

Sens. Durbin and Cassidy introduce the bipartisan REMEDY Act to discourage innovator drug companies from filing additional patents to delay generic co...

latest-news-card-1
Medical Devices

FDA Clears Teleflex Perfusion Balloon Catheter

FDA clears a Teleflex 510(k) for its Ringer Perfusion Balloon Catheter for use in percutaneous transluminal coronary angioplasty procedures.

latest-news-card-1
Federal Register

Psychopharmacologic Drugs Panel Renewal

Federal Register notice: FDA renews its Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charter expiration date.

latest-news-card-1
Human Drugs

FDA Explains New LabelComp Tool

FDA says its new LabelComp artificial intelligence tool automates the identification of adverse event changes in drug labeling updates.

latest-news-card-1
Human Drugs

FDA OKs Expanded Jemperli Indication

FDA approves an sBLA expanding the endometrial cancer indication for GlaxoSmithKlines Jemperli.

latest-news-card-1
Human Drugs

Abbott Device Correction on FreeStyle Libre 3

Abbott issues a medical device correction for a small number of FreeStyle Libre 3 sensors because they may provide incorrect high glucose readings.

latest-news-card-1
Human Drugs

Novartis Sues FDA to Reverse Generic Entresto OK

Novartis files a lawsuit against FDA that seeks to reverse the agencys recent approval of MSN Laboratories generic version of Novartiss Entresto (sacu...