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False or Misleading Xeomin Promotion: FDA

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FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berku...

Respironics Recalls Garbin Ventilators

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Philips Respironics recalls (Class 1) its Garbin Evo ventilators due to the potential for aerosol deposit accumulation on the devi...

Innovative Manufacturing Technologies Comments

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Two stakeholder trade associations suggest changes to an FDA strategy document on innovative manufacturing technologies.

Trump Taps RFK Jr. as HHS Secretary

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President-elect Donald Trump picks controversial FDA critic and vaccine skeptic Robert F. Kennedy Jr. as his secretary for Health ...

Require Studies for Prednisolone Eye Drops: DifGen

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DifGen asks FDA to require long-term refrigerated stability studies for any generic form of its Prednisolone Ophthalmic Solution 1...

Workshop on Patient Experience Data

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Federal Register notice: FDA announces a 12/13 virtual public workshop entitled Patient-Focused Drug Development: Workshop to Disc...

Adaptimmune Therapeutics Plan Lete-Cel BLA

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Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoi...

7 Observations on U.S. Specialty FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility i...

Oligonucleotide-Based Therapeutic Assessment

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FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.

NovaBone Putty Cleared for Intervertebral Disc Repair

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FDA clears a NovaBone Products 510(k) for its NovaBone Putty and its expanded use in the intervertebral disc space.