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FDA Continues Hold on Cystic Fibrosis Trial

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FDA maintains a clinical hold on an Insmed Phase 3clinical trial for Arikace (liposomal amikacin for inhalation) in cystic fibrosi...

FDA Clears a Cardium Therapeutics 510(k) for Wound Product

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FDA clears a Cardium Therapeutics 510(k) for the Excellagen professional-use, sterile, syringe-based advanced wound care product f...

FDA Approves Januvia/Zocor Combo Pill

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FDA approves an MSD International GmbH Clonmel NDA for Juvisync (sitagliptin and simvastatin), a fixed-dose convenience combinatio...

FDA, CMS Pilot Parallel Reviews for Devices

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FDA and the Centers for Medicare & Medicaid Services (CMS) launch a parallel review two-year pilot program for approving medical d...

Correction Made in OMB Approval of Tobacco Exemption Info

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Federal Register Notice: FDA corrects an expiration date in a 9/12 Federal Register notice on OMB approval of an information colle...

Panel to Discuss Drug Development for Smallpox Infection

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Federal Register Notice: FDAs Antiviral Drugs Advisory Committee will meet 12/14-15 to discuss developing drug to treat smallpox i...

Workshop to Discuss Drug Abuse Liability Assessment

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Federal Register Notice: FDA plans a public workshop 11/10 to discuss the science of abuse liability assessment.

FDA Says AlloStem Product Needs BLA

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FDA says AlloSource needs to submit a BLA for its AlloStem cell-scaffold product, which is intended to be used as a bone graft.

FDA Proposes User Fees for Device Reviewer Bonuses

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FDA proposes using user fee money to award retention bonuses to CDRH device reviewers to help improve consistency with device revi...

Pfizer Sues Watson Labs to Block Generic Embeda

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Pfizer sues Watson Laboratories over an ANDA seeking approval to market a generic copy of King Pharmaceuticals' Embeda.