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Group Wants HealthFairs CV Screening Ads to Stop

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Public Citizen urges the Federal Trade Commission to investigate cardiovascular disease screening company HealthFairs direct-to-co...

FDA Fast Track for Halozyme Pancreatic Cancer Therapy

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FDA grants Halozyme Therapeutics a fast track designation for Halozymes PEGPH20 (PEGylated recombinant human hyaluronidase) in com...

New England Governors Ask HHS to Rescind Zohydro Approval

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The governors from five New England states urge HHS to rescind FDAs approval of Zogenix Zohydro ER (hydrocodone) because it does n...

Overall FDA Recalls Down: Stericycle

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Stericycle says that in the second quarter of this year, FDA had the fewest recalls of drugs, medical devices, and food tracked in...

Drug Shortage MAPP Issued

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CDER issues a MAPP with drug shortage management procedures.

FDA Implementing eCTD Module 1 Update in 2015

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FDA says it expects to implement in the first quarter of 2015 its eCTD Module 1 update.

Petition Wants HyQvia Restrictions

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Hyman, Phelps & McNamara asks FDA to require specific labeling statements and risk mitigation activities for any approval of Baxte...

FDA Breakthrough Designation for Parkinsons Therapy

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FDA grants Acadia Pharmaceuticals a breakthrough therapy designation for Nuplazid (pimavanserin) for treating Parkinsons disease p...

Cabozantinib Trial Misses Primary Endpoint

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Exelixis says a Phase 3 trial of its Cometriq fails to meet its overall survival endpoint for metastatic castration-resistant pros...

FDA Seeks Comments on Duchenne Muscular Dystrophy Guide

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FDA seeks comments on a recent patient advocacy-drafted guidance on developing drugs for Duchenne muscular dystrophy.