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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...

Human Drugs

Workshop on Patient Experiences in Clinical Trials

FDA hosts a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to develop and identify what is most import...

DTC Drug Pricing Amendment Shot Down on Hill

House Republicans derail a Trump-supported legislative measure that would have required drug companies to include prices in their direct-to-consumer a...

Federal Register

Workshop on Blood Pathogen Reduction Technologies

Federal Register notice: FDA announces an 11/28 public workshop entitled Pathogen Reduction Technologies for Blood Safety.

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 9/14/2018.

Federal Register

Guide on Consensus Standards Recognition/Withdrawal

Federal Register notice: FDA makes available a draft guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards.