FDA Related News

Human Drugs

Bill Introduced to Spur Pediatric Rare Disease Studies

Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) introduce a bipartisan bill entitled Innovation in Pediatric Drugs Act (S 4905) that would a...

Medical Devices

Smiths Medical Software Correction for Infusion Pumps

Smiths Medical corrects software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may occur if the device i...

Loper Bright May End FDA Speech Ban: Attorney

Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new Loper Bright Suprem...

Medical Devices

Medtronic Recalls Nerve Monitor

Medtronic recalls (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative responses.

Medical Devices

Pentax Duodenoscope Cleared for New Reprocessing

FDA clears a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscopes compatibility with Advanced Sterilization Products S...

Federal Register

Anesthetic/Analgesic Drugs Panel Renewed

Federal Register notice: FDA announces the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two.

Human Drugs

Petition Seeks Govt Action to Allow Generic Semaglutide

Public Citizen petitions HHS to use its authority under 28 USC. 1498 to permit generic competitors to manufacture Novo Nordisks semaglutide, the acti...

Human Drugs

Drug Safety Committee Renewed

FDA renews the Drug Safety and Risk Management Advisory Committee for an additional two years.

Human Drugs

Labcorp Gets De Novo for Tumor Assay

FDA grants Labcorp a de novo marketing authorization for its PGDx elio plasma focus Dx kitted assay.

Medical Devices

Exactech Joint Replacement Device Recall Updated

FDA updates an Exactech recall involving its joint replacement devices manufactured between 2004 and 2021.