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Regenerelle Marketing Unapproved HCT/P Products: FDA

[ Price : $8.95]

An FDA Notice of Violation says Fairport, NY-based Regenerelle is marketing stem cell and exosome products without required drug a...

Integra Recalls Products Over Endotoxin Testing

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Integra LifeSciences recalls all products manufactured at its Boston, MA facility due to inadequate endotoxin testing.

PhRMA, BIO Commend FDA Digital Health Efforts

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PhRMA and BIO praise FDA efforts to use digital health technology in drug and biologic regulatory decisions.

Panel to Discuss Ipsens Palovarotene NDA

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Federal Register notice: FDA announces a 6/28 advisory committee meeting to discuss an Ipsen Biopharmaceuticals NDA for palovarote...

Phathom Resubmits Vonoprazan NDA

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Phathom Pharmaceuticals resubmits its NDA for vonoprazan tablets to treat erosive gastroesophageal reflux disease, responding to a...

Celltrion Biosimilar Copy of Humira Approved

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FDA approves a Celltrion BLA for Yuflyma (adalimumab-aaty), biosimilar copy of AbbVies blockbuster Humira.

Info Collection on FDA Service Delivery Feedback

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Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for the Collection o...

Generally Accepted Scientific Knowledge Guidance

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FDA publishes a draft guidance on using generally accepted scientific knowledge in drug and biological product applications.

FDA Extends Review of Sarepta Gene Therapy

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FDA extends by three weeks its review of a Sarepta Therapeutics BLA for SRP-9001 (delandistrogene moxeparvovec), a gene therapy pr...

Tox Study Whole Slide Imaging Guidance

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FDA publishes a Q&A guidance on using and managing whole slide images used during histopathology assessment and/or pathology peer ...