Number To Know…9
US FDA will select nine manufacturers for a voluntary "Premarket Approval Application Critical to Quality" pilot program to assist the agency's review of the manufacturing section of a PMA and post-approval inspections, and provide a change for firms to skip a pre-approval audit.
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Device-Makers Can Forego US FDA Pre-Approval Inspections By Joining New 'Critical-To-Quality' PMA Pilot
Nine manufacturers will be selected to play in the agency's voluntary "Premarket Approval Application Critical to Quality" (PMA CtQ) pilot program. Participants will "discuss device design and manufacturing process quality information with FDA early on" to assist "in its review of the PMA manufacturing section and post-approval inspections," the agency says in a notice set to publish in the Sept. 12 Federal Register.
The Swiss giant is hoping to get seven more approvals for its blockbuster immunology drug over the next 10 years.
Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.