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Generics Office Expands In-person Meetings

[ Price : $8.95]

CDERs Office of Generic Drugs Office (OGD) expands its post-pandemic return to in-person face-to-face meetings with industry.

Pilot Seeks to Advance Rare Disease Drugs

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FDA announces a new pilot program to further accelerate the development of novel drug and biological products for rare diseases. ...

AST Device Labeling Breakpoints Guidance

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FDA says it is implementing immediately a new guidance with information about updating susceptibility test interpretive criteria b...

De Novo e-Submission Template Guidance

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FDA publishes a draft guidance on the electronic submission format for de novo medical device requests.

Petition Seeks Warning on Fluoroquinolone Guides

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Three people petition FDA to add information from the fluoroquinolone Boxed Warning to the top of the drugs Medication Guide as a ...

BrainStorm Cell Therapy Rejected by Panel

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An FDA advisory committee votes 17 to 1 against approving a BrainStorm Cell Therapeutics BLA for NurOwn, an investigational mesenc...

FDA Approves Entyvio Subcutaneous Dosing

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FDA approves a subcutaneous administration for Takedas Entyvio (vedolizumab) for maintenance therapy in adults with moderately to ...

Biologic Adverse Event Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Experience Reporting For Licen...

Drug Application Info Collection Revision

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Federal Register notice: FDA seeks comments on an information collection revision entitled Applications for FDA Approval to Market...

FDA OKs Amicus Pompe Disease Combo Drugs

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FDA approves an Amicus Therapeutics NDA for Pombiliti (cipaglucosidase alfa-atga) in combination with Opfolda (miglustat) 65mg cap...