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Human Drugs

FTC Targets Drug Rebate Schemes Affecting Formularies

The Federal Trade Commission says it is ratcheting up enforcement against any illegal bribes and rebate schemes that give drugs preferential formulary...

Human Drugs

FDA Posts 3 Nanotechnology Standards for Liposomes

FDAs National Center for Toxicological Research announces the publication of three International Test Method Standards in Nanotechnology by the Americ...

Federal Register

Drug Compounding Information Collection Revision

Federal Register notice: FDA seeks comments on an information collection revision entitled Human Drug Compounding Under Sections 503A and 503B of the ...

Federal Register

Info Collection on Influenza A Reagents Guide

Federal Register notice: FDA sends to OMB an information collection extension entitled Guidance on Reagents for Detection of Specific Novel Influenza ...

Human Drugs

Bill Would Establish FDA/USPTO Patent Task Force

Sens. Dick Durbin (D-IL), chair of the Senate Judiciary Committee, ranking member Chuck Grassley (R-IA) and Thom Tillis (R-NC) introduce bipartisan le...

Medical Devices

Guide on Power Morcellator Containment Systems

CDRH makes available a draft guidance on Power Morcellator containment systems clinical performance assessments.

Medical Devices

Act on Medical Dye Shortage: 30 GOP Representatives

Some 30 GOP House members call on President Biden to take steps to alleviate a shortage of intravenous contrast agents.

Human Drugs

FDA Updates Off-Patent, Off-Exclusivity List

FDA publishes the latest update for its list of off-patent, off-exclusivity drugs for which there are no approved generics.

Federal Register

Guide on Regenerative Medicines Consensus Standards

Federal Register notice: FDA makes available a draft guidance entitled Voluntary Consensus Standards Recognition Program for Regenerative Medicine The...

Federal Register

Info Collection Revision on CLIA Waivers

Federal Register notice: FDA seeks comments on an information collection revision entitled Administrative Procedures for Clinical Laboratory Improveme...