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Selectors Sought for Patient Engagement Panel

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Federal Register Notice: FDA seeks participants for selecting consumer representatives for the Patient Engagement Advisory Committ...

FDA Breakthrough Not Really a Breakthrough: JAMA Authors

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Carnegie Mellon researchers say FDAs use of the term breakthrough when discussing the approval of new drugs could be misleading to...

FDA Priority Review for Amgen sNDA for Kyprolis

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FDA accepts for priority review an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection for patients with relapsed mult...

Ex-Merck General Counsel Kuhlik Joins FDA

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Former Merck general counsel Bruce Kuhlik joins FDA as senior advisor to the commissioner.

FDA Accepts BLA for Primary Immunodeficiency Therapy

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FDA accepts for review an ADMA Biologics BLA for RI-002, and investigational therapy for treating primary immunodeficiency patient...

FDA Sets Up Device Patient Engagement Committee

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Federal Register Notice: FDA establishes the Patient Engagement Advisory Committee to provide advice to the commissioner on issues...

FDA Posts Product-Specific BE Recommendations

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Federal Register Notice: FDA makes available additional draft and revised draft product-specific bioequivalence recommendations.

Panel to Discuss Teva BLA for Asthma

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 12/9 to discuss a Teva Pharmaceutical BLA to im...

Nominations Sought for Device Patient Engagement Panel

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Federal Register Notice: FDA requests nominations for members to serve on the CDRH Patient Engagement Advisory Committee.

Inrange Petitions FDA to Act Against Unapproved Device

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Inrange Systems petitions FDA asking that it detain a competitors product because it is allegedly not cleared or approved for sale...