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Cresilon Hemostatic Gel Cleared

[ Price : $8.95]

FDA clears a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure.

Orthopedic Implant Guide Guidance

[ Price : $8.95]

FDA publishes a draft guidance with recommendations on information to go in regulatory submissions for patient-matched guides to o...

Oncology Drug Approval Trends

[ Price : $8.95]

FDA and National Cancer Institute researchers document an increase in oncology drug approvals since 2000 that they expect to conti...

CBER Updates 2023 Guidance Agenda

[ Price : $8.95]

CBER issues a revised guidance agenda for 2023 with 13 likely guidances in three categories.

3 GOP Senators Push FDA on Chinese Cancer Drugs

[ Price : $8.95]

Republican Sens. Scott, Vance, and Braun criticize FDAs decision to allow the importation of some Chinese-approved cancer drugs to...

Comments on OPDP Quantitative Claims Research

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Two stakeholders raise questions about proposed Office of Prescription Drug Promotion research into quantitative claims in direct-...

FDA Reiterates NuVasive Device Indications

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FDA reiterates the indication and instructions for use of the NuVasive Specialized Orthopedics Precice Intramedullary Limb Lengthe...

Candela Laser Cleared for Capillary Malformations

[ Price : $8.95]

FDA clears a Candela 510(k) to expand the labeled indication of its Vbeam Pulsed Dye Laser for use of the 595 nm wavelength to inc...

Overject AI Technology for Dental Caries Cleared

[ Price : $8.95]

FDA clears an Overjet 510(k) to expand the use of its artificial intelligence technology for predicting tooth decay in younger pat...

Pfizer/OPKO Pediatric Growth Hormone OKd

[ Price : $8.95]

FDA approves a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for t...