FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Group Seeks Removal of Black Box on Contrast Agents

International Contrast Ultrasound Society petitions FDA urging it to remove boxed warnings from ultrasound contrast agents based on current highly fav...

Human Drugs

Pharmaceutical Laboratories and Consultants Warned

FDA warns Pharmaceutical Laboratories and Consultants about repeat CGMP violations and other issues in its work as a contract laboratory testing OTC d...

Human Drugs

FDA Denies Vaccine Safety Petition

FDA denies a 2009 petition asking it to recall vaccines containing unsafe ingredients.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include ITG-Medev, Jabones Y Productos and Pharmaceutical Laboratories and Consultants.

Federal Register

Panel Meeting Docket Corrected

Federal Register notice: FDA corrects a notice entitled Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of...

Human Drugs

FDA Clears WAT Medical Migraine Device

FDA clears a WAT Medical 510(k) for its HeadaTerm for treating migraine headaches.

Federal Register

Oncologic Drugs Committee Renewed for 2 Years

Federal Register notice: FDA announces the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond the charter expiration...

Human Drugs

New Reimbursement Scheme for New Antibiotics Needed: FDA

Severing FDAs historical independence from drug economics, commissioner Scott Gottlieb suggests that new innovative payment/reimbursement mechanisms s...

Federal Register

Info Collection on Compounding Bulk Drug Substances

Federal Register notice: FDA seeks comments on a proposed information collection entitled Clinical Use of Bulk Drug Substances Nominated for Use in Co...

Human Drugs

PhRMA Supports Streamlined GMPs for Combo Products

Pharmaceutical Research and Manufacturers of America says it supports FDAs efforts to identify alternative or streamlined mechanisms for complying wit...