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FDA Accepts Bayer BLA for Hemophilia A Therapy

[ Price : $8.95]

FDA accepts a Bayer BLA for BAY94-9027, an extended half-life PEGylated recombinant human Factor VIII compound for treating hemoph...

Nominations Sought for Pediatric Advisory Committee Rep

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Federal Register notice: FDA seeks nominations for a nonvoting industry representative to serve on its Pediatric Advisory Committe...

Public Meeting on FDA Hiring and Retention

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Federal Register notice: FDA announces an 11/30 public meeting on Assessment of FDA Hiring and Retention that will share high-leve...

Design Medical Devices for Interoperability: CDRH

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CDRH senior science advisor Heather Agler suggests that medical device manufacturers design their products with interoperability a...

FDA Approves Vyzulta for Intraocular Pressure

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FDA approves a Bausch + Lomb and Nicox NDA for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), indicated for reducing ...

Pfizer Addressing Hospira Problems to Remediate by Next Year

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Pfizer officials say they have submitted a corrective and preventative action plan to FDA on remediating GMP issues at Hospira leg...

Lancet Oncology Commission Priorities

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The Lancet Oncology Commission outlines future cancer research priorities for the U.S. Cancer Moonshot.

Advisors Back Indivior Opioid Use Disorder Drug

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Members of two FDA advisory committees vote to recommend approval of Indiviors RBP-6000 for treating adults with opioid use disord...

FDA Clears Luminex Aries Strep Assay

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FDA clears a Luminex 510(k) for the ARIES Group A Strep Assay for detecting Streptococcus pyogenes from throat swab specimens usin...

Comments on Device Software Change Guidance

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Stakeholders raise varying issues on an FDA draft guidance on submitting a 510(k) for medical device software changes.