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Marketing

Sen. Durbin Queries FDA on Drug Promo Staff Cuts

Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDERs Office of Prescription Drug Promotion can adequately regulate prescription dru...

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FDA General

To Make FDA Great Again, Impeach RFK Jr.

To make FDA great again, FDA Webview editor James G. Dickinson urges Congress to impeach HHS secretary RFK Jr. on four counts of misleading lawmakers....

Human Drugs

Inspection Issue at AACE Pharmaceuticals

FDA warns Fairfield, NJ-based AACE Pharmaceuticals about the lack of an adequate quality control unit for its drug manufacturing facility.

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Medical Devices

Quality System Issues in Spains Sedecal Inspection

FDA warns Madrid, Spain-based Sedecal about Quality System violations in its production of mobile digital radiography systems.

Medical Devices

Warning Letter to Kabe Follows Recent Safety Alert

After issuing a safety alert in April, FDA follows up with a Warning Letter to Kabe Labortechnik, the German manufacturer of the RAM Scientific SAFE-T...

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FDA General

Congress Should End Government Layoffs: Professor

Harvard University health policy professor Benjamin Sommers calls on Congress to stand up against cuts in the federal workforce that he says are hurti...

Animal Drugs

Prothena Scraps Birtamimab After Phase 3 Miss

Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet primary or second...

Biologics

Covid Vaccine Nixed for Children/Pregnant Women

HHS removes Covid-19 vaccine recommendations for healthy children and healthy pregnant women from CDCs recommended immunization schedule.

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Human Drugs

Gene Therapy Trial on Hold After Death

FDA places a clinical hold on a Rocket Pharmaceuticals Phase 2 pivotal trial for RP-A501, an investigational gene therapy for Danon disease, following...

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Medical Devices

FDA Clears Olympus Endoscope Series

FDA gives 510(k) clearance to the latest Olympus endoscopes that feature new extended depth of field technology.