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New Guidance Promotes More Trial Diversity

[ Price : $8.95]

FDA publishes a draft guidance updating a 2016 guidance by telling medical product sponsors what should be included in a Race and ...

House Committee Releases McKinsey Report

[ Price : $8.95]

The House Committee on Oversight and Reform issues a report demonstrating McKinsey & Companys conflicts of interest in working for...

pH Adjuster Waiver Request Guidance

[ Price : $8.95]

FDA publishes a draft guidance to help ANDA applicants prepare and submit pH adjuster waiver requests for specific types of drugs.

Gene Therapies Panel Reviews 2 bluebird BLAs

[ Price : $8.95]

Federal Register notice: FDA announces a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss two blue...

Device Guides on Denture Base Screws

[ Price : $8.95]

Federal Register notice: FDA makes available two final device-specific guidance documents for the Safety and Performance Based Pat...

FDA Debars Raventos Over Falsifying Trial Data

[ Price : $8.95]

Federal Register notice: FDA permanently debars Lisett Raventos from providing services in any capacity related to an approved or ...

Animal Drug Compounding Guidance

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FDA publishes a final guidance on its approach to enforcement involving animal drugs compounded from bulk drug substances.

Golfer James Hahn Promoting Licart

[ Price : $8.95]

Pro golfer James Hahn is partnering with IBSA Pharma to promote its Licart prescription topical NSAID.

FDA STeP Designation for Pear Pain Product

[ Price : $8.95]

FDA grants Safer Technologies Program designation for a Pear Therapeutics pain control device.

Aeglea Bio BLA for Arginase 1 Deficiency

[ Price : $8.95]

Aeglea BioTherapeutics files a BLA for pegzilarginase for treating Arginase 1 Deficiency.