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Human Drugs

FDA Approved Expanded Verzenio Use

FDA approves Eli Lillys Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treating postmenopaus...

Federal Register

Advisory Panel to Review NDA on Opioid Withdrawal Drug

Federal Register notice: FDA announces a 3/27 Psychopharmacologic Drugs Advisory Committee meeting.

Federal Register

Public Meeting on Complex Clinical Trial Designs

Federal Register notice: FDA announces a 3/20 public meeting entitled Promoting the Use of Complex Innovative Designs in Clinical Trials.

Human Drugs

FDA Planning 2 Guidances on Opioid Addiction

FDA expects to release soon two new draft guidances intended to advance medication-assisted treatment for opioid addiction.

Biologics

FDA Probes Flu Vaccine Shortcomings

FDA commissioner Scott Gottlieb says the agency is investigating why this years flu vaccine was not very effective against one strain H3N2.

Human Drugs

Hospira Recalling 3 Labetalol Lots

FDA says Hospira has recalled three lots of labetalol hydrochloride due to cracks on vial rim surfaces.

Federal Register

CDER Workshop on Stakeholder Engagement

Federal Register notice: CDER announces a 4/3 public workshop entitled CDER and You: Keys to Effective Engagement.

Medical Devices

Medtronic Class 1 Recall of Pace Makers

Medtronic begins a Class 1 recall of its Cardiac Resynchronization Therapy with Defibrillation and Implantable Cardiovert-Defibrillators due to a defe...

Federal Register

FDA Guide on Drug Starting Materials

Federal Register notice: FDA makes available a guidance on Q11 Development and Manufacture of Drug Substances Questions and Answers (Chemical Entitie...

Medical Devices

FDA, Others Issue Duodenoscope Sampling Protocols

FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology announce the availability of voluntary, standardized du...