FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
FDA General

Trumps HHS Pick Will Divest Pharma Stock Ownership

President-elect Donald Trumps pick to serve as HHS secretary, House Budget Committee chair Tom Price (R-GA), agrees to divest stock ownership in over ...

Human Drugs

ICH Proposes Revisions to Good Clinical Practice Guidelines

The International Council for Harmonization says in a new white paper that it aims to renovate its guidelines on good clinical practice.

FDA General

FDA WEBVIEW CLOSED FOR MLK DAY

FDA Webviews newsroom closes Monday (1/16) in observance of Martin Luther King day.

Human Drugs

FDA Issues 2 Drug Compounding Guidances

FDA issues one final and one revised draft guidance on drug compounding.

Human Drugs

Cancer Patients Should Avoid PNC-27: FDA

FDA cautions against using any PNC-27 product promoted online as a cancer treatment.

Human Drugs

FDA Chooses Biologic Nonproprietary Suffix Format

FDA settles on a biologic product nonproprietary naming convention that includes a random four-letter suffix added to the nonproprietary name.

FDA General

Price Confirmation Likely Mid-February: Alexander

Senate HELP Committee chairman Lamar Alexander says the Senate will not likely vote to confirm Rep. Tom Price as HHS secretary until mid-February.

Human Drugs

Draft Guide on Generic 180-day Exclusivity

FDA posts a draft guidance on 180-Day Exclusivity: Questions and Answers that addresses questions that have been raised about Food, Drug, and Cosmetic...

Human Drugs

FDA Guide on Multiple Endpoints in Clinical Trials

FDA posts a draft guidance on Multiple Endpoints in Clinical Trials that discusses the problems posed by multiple endpoints in the analysis and interp...

Human Drugs

Kremers Wants FDA Ordered to Provide ANDA Info

Kremers Urban Pharmaceuticals asks the DC federal court to order FDA to provide records the company needs to participate in an agency hearing on its p...