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Food Effects Guidance

[ Price : $8.95]

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

Dear Doctor Letters Info Collection Extension

[ Price : $8.95]

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

Breakthrough Therapy Rescission Guidance

[ Price : $8.95]

FDA publishes a draft guidance explaining how it periodically assesses drugs that have been granted breakthrough therapy designati...

Rigorously Scrutinize Accelerated Approval Program: Kumar

[ Price : $8.95]

University of Illinois psychiatry professor Anand Kumar calls on FDA to closely reevaluate the accelerated approval program to be ...

Medtronic Class 1 Recall of HeartWare HVAD Batteries

[ Price : $8.95]

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

House Appropriators Approve $341 Million FDA Boost for 2023

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The House Appropriations Committee votes 31 to 26 to approve an FDA spending bill for fiscal year 2023 that will boost the agencys...

FDA Clears Medtronic LigaPASS

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FDA clears the Medtronic LigaPASS ligament augmentation system.

Expanded Indication for Mercks Vaxneuvance

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FDA approves an expanded indication for Mercks Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children six week...

Draft New Compounding MOU: Association Exec

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Alliance for Pharmacy Compounding CEO Scott Brunner calls on FDA to abandon current efforts to draft a drug compounding memorandum...

CURE ID App Updated

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FDA and the National Center for Advancing Translational Sciences update the CURE ID crowd-sourcing drug repurposing app.