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Federal Register

Info Collection on 510(k) 3rd-Party Review Program

Federal Register notice: FDA seeks comments on an information collection extension entitled 510(k) Third-Party Review Program (OMB Control Number 0910...

Federal Register

Info Collection on Device Registration/Listing

Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment Registration and Device Listing for Manufacturers...

Explain Need for Trial Diversity: Caplan

New York University bioethicist Arthur Caplan says those calling for greater diversity in clinical trials should clearly explain the benefits of such ...

Human Drugs

FDA 5-Year Plan to Treat Diseases Like ALS

FDA issues a five-year action plan for fostering and advancing drug development for rare neurodegenerative diseases such as ALS.

Human Drugs

Accelerated Approval for Novartis Combo Therapy

FDA grants Novartis accelerated approval for Tafinlar (dabrafenib) plus Mekinist (trametinib) for treating certain patients six years of age and older...

Human Drugs

Food Effects Guidance

FDA publishes a guidance on clinical pharmacology considerations in assessing food effects in INDs and NDAs.

Federal Register

Dear Doctor Letters Info Collection Extension

Federal Register notice: FDA seeks comments on an information collection extension entitled Improving Communication of Important Safety Information 2...

Human Drugs

Breakthrough Therapy Rescission Guidance

FDA publishes a draft guidance explaining how it periodically assesses drugs that have been granted breakthrough therapy designation and rescinds thos...

Human Drugs

Rigorously Scrutinize Accelerated Approval Program: Kumar

University of Illinois psychiatry professor Anand Kumar calls on FDA to closely reevaluate the accelerated approval program to be sure it only uses bi...

Medical Devices

Medtronic Class 1 Recall of HeartWare HVAD Batteries

Medtronic recalls (Class 1) one lot of batteries for its HeartWare Ventricular Assist Device due to welding defects that allow separation of the two c...