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Human Drugs

Ways to Overcome Drug Company Regulatory System Abuse

Researchers suggest ways Congress could clamp down on abuses of FDA regulatory processes that drug companies use to delay generic competition.

FDA General

FDA Part of Unified Web Site for Biotechnology Regulation

FDA, the Agriculture Department, and EPA launch a unified Web site for biotechnology regulation.

Medical Devices

New CDRH Tool for Scope Reprocessing Assurance

CDRH scientists and engineers develop a new tool to help hospitals determine how clean an endoscope is after it has been reprocessed.

Federal Register

Info Collection on Administrative Practice/Procedures

Federal Register notice: FDA seeks comments on an information collection revision for General Administrative Practice and Procedures.

Human Drugs

Much of Higher Drug Spending Not Going to Companies: PhRMA

A PhRMA-funded study says drug companies are not retaining much of the increased drug spending in the U.S.

Medical Devices

Penumbra Expanded Indication for Aspiration Device

FDA clears a Penumbra 510(k) for an expanded indication for its Indigo Aspiration System treating pulmonary embolisms.

Federal Register

Public Meeting on Modernizing FDA Data Strategy

Federal Register notice: FDA announces a 3/27 public meeting entitled Modernizing FDAs Data Strategy.

Federal Register

Comments Extended on Certificates of Confidentiality Guide

Federal Register notice: FDA extends until 1/24 the comment period for a draft guidance entitled Certificates of Confidentiality; Guidance for Sponsor...

Federal Register

FDA Focus Group Info Collection Extension

Federal Register notice: FDA seeks comments on an information collection extension on Focus Groups as Used by the Food and Drug Administration (All FD...

Federal Register

Comments Extended on Homeopathic Drug Guide

Federal Register notice: FDA extends until 3/23 the comment period on a revised draft guidance entitled Drug Products Labeled as Homeopathic.