FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Renews Patient Engagement Advisory Committee for 2 Years

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of the Patient Engagement Advisory Committee for an additional two years.

Comments Sought on Radiopharmaceuticals Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Regulations for In Vivo Radiopharmaceutical...

Philips Consent Decree Posted

[ Price : $8.95]

FDA Webview posts the court-approved consent decree between FDA and Philips North America that prohibits manufacturing, processing...

Suggestions for Device Guidance Changes

[ Price : $8.95]

Three stakeholders suggest language changes for an FDA draft guidance on submitting a 510(k) for a change to an existing device.

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Approves Vyzulta for Intraocular Pressure

[ Price : $8.95]

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

[ Price : $8.95]

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