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Human Drugs

Hypertension Combination Drug Guidance

FDA issues a draft guidance to help sponsors develop fixed-dose combination hypertension drugs.

Federal Register

Comments Extended on 510(k)/CLIA App Studies

Federal Register notice: FDA extends the comment period on a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Improveme...

Human Drugs

Trulance NDA Approved for Expanded Indication

FDA approves a Synergy Pharmaceuticals NDA for Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with consti...

Medical Devices

Policy Modifications for IDE Classification

A CDRH Webinar discusses reasons for a finalized guidance on how the agency categorizes IDEs to support CMS in making coverage decisions.

Human Drugs

Endo Agrees to Compounding Suit Stay

Endo says it will follow an FDA request that it agree to stay its suit against the agency over bulk compounding of new drugs.

Medical Devices

FDA Explains PMA Rules for Dermatology Devices

Three CDRHers discuss various PMA applications for dermatology medical devices.

Human Drugs

Synthon Gains Fast Track for Breast Cancer Therapy

FDA grants Synthon Biopharmaceuticals a fast track designation for its investigational anti-HER2 antibody-drug conjugate [vic-]trastuzumab duocarmazin...

Human Drugs

AngioDynamics Expedited Pathway for Pancreatic Cancer Device

FDA grants AngioDynamics an expedited access pathway designation for its NanoKnife System and a proposed indication for use in treating Stage 3 pancre...

FDA, FTC Warn Makers of 12 Opioid Cessation Products

FDA and FTC warn marketers and distributors of 12 unapproved opioid cessation products that they are selling their products illegally.

Biologics

FDA OKs Treos Bio IND for Colorectal Cancer Vaccine

FDA approves a Treos Bio IND for PolyPEPI 1018 to allow a Phase 1 study to proceed with the investigational precision cancer vaccine for patients with...