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The FDA has received heavy pushback from industry groups on its revised plan to collect quality metrics data from manufacturers, according to public comments on two volunteer pilots, the Site Visit and Quality Metrics (QM) Feedback programs. Read More
The FDA and the U.S. Patent and Trademark Office (PTO) will be walking the thin line between preserving patents as an incentive for groundbreaking drug developments and limiting them to allow the emergence of cost-effective generic forms of those drugs. Read More
The use of continuous manufacturing (CM) technology resulted in applicants getting FDA approval faster when compared to batch manufacturing products, according to an FDA audit published in the International Journal of Pharmaceuticals. Read More
Five Republican senators have called on the Senate Finance Committee to hold hearings on a proposed bill that aims to cap the cost of insulin at $35 a month before it is put before the full chamber for a vote. Read More