FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on Compounding Drugs Affected by Hurricanes

[ Price : $8.95]

FDA posts an immediately-in-effect guidance titled Temporary Policies for Compounding Certain Parenteral Drug Products that addres...

Performance Criteria for Endosseous Dental Implants

[ Price : $8.95]

FDA posts a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Abutments Performance Criteria for S...

FDA OKs Pfizers Hympavzi for Hemophilia A and B

[ Price : $8.95]

FDA approves a Pfizer BLA for Hympavzi (marstacimab-hncq) for preventing or reducing bleeding episodes in hemophilia A or B patien...

Sanofi Scraps Phase 2 Multiple Sclerosis Study

[ Price : $8.95]

Sanofi discontinues a Phase 2 study evaluating the safety and efficacy of oditrasertib (SAR443820/DNL788) on serum neurofilament l...

Nanchang Anobri FDA-483 Released

[ Price : $8.95]

FDA releases the form FDA-483 with 12 observations from a 2023 inspection at Chinas Nanchang Anobri drug manufacturing facility.

Zyno Medical Recalls Z-800 Infusion Devices

[ Price : $8.95]

Zyno Medical recalls (Class 1 device correction) various models of its Z-800 Infusion System due to a defect in the air in-line so...

Priority Voucher Used on Tremfya sBLA

[ Price : $8.95]

Federal Register notice: FDA announces that it approved a product submission that redeemed a priority review voucher Johnson & Jo...

Aqualex FDA-483 Has 6 Inspection Observations

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from a 2023 inspection at the Republic of Koreas Aqualex cosmetic and drug man...

Trial Planned for New Weight Loss Drug

[ Price : $8.95]

FDA accepts an Antag Therapeutics IND for its lead molecule, AT-7687, to begin a Phase 1 clinical trial to evaluate it for treatin...

CDRH Prioritized FY 2024 Guidance List

[ Price : $8.95]

CDRH posts a list of final and draft guidances it expects to publish in FY 2024.