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FDA Tells Acadia that Nuplazid sNDA has Deficiencies

[ Price : $8.95]

FDA tells Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating...

FDA Issues Section 506J Notification Obligation Table

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FDA issues a table with recommendations for medical device manufacturers to use in association with an earlier pandemic guidance o...

Sandoz Sues FDA Over Aubagio NCE Status

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Sandoz asks the DC federal court to order FDA to set aside its award of new chemical entity status and exclusivity to Sanofi Genzy...

Generic Drug Correspondence Guidance Inadequate: AAM

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The Association for Accessible Medicines raises several concerns with an FDA final guidance on controlled correspondence related t...

Brain Scientifics NeuroCap Cleared

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FDA clears a Brain Scientific 510(k) for its NeuroCap device, an advanced electroencephalogram electrode array used to obtain rapi...

Safety Studies Could Help Galapagos Jyseleca: Report

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GlobalData says that positive results from two Jyseleca testicular safety studies could lead to FDA approval for an indication for...

IND Cleared for Ultragenyx mRNA Therapy

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FDA clears an Ultragenyx Pharmaceutical IND for UX053, an investigational mRNA therapy being evaluated for treating Glycogen Stora...

Animal Drug Regs Updated on Review Actions

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applica...

CDRH Workshop on Device Consensus Standards

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CDRH announces a 4/13 workshop on how medical device developers can use consensus standards in premarket submissions.

Drug Marketing Violation Letters Separated: FDA

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CDERs Office of Prescription Drug Promotion no longer maintains an aggregated Web page of recent Warning Letters and Untitled Lett...