Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type 1 diabetes patients.
Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new Quality Management System Regulation.
Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type 1 diabetes patients.
Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new Quality Management System Regulation.
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in generic prostate cancer bicalutamide tablets produced by Intas and Sun at facilities in India.
FDA asks manufacturers of generic Accutane to update the drugs’ labeling.
