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The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing. Read More
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More
The FDA warned supplement manufacturer Sanapac for GMP violations, adulterated products and misbranding following two inspections in late 2016. Read More
The PTO’s Patent Trial and Appeal Board ruled in favor of SteadyMed in the drug manufacturer’s challenge to a patent held by United Therapeutics over its Remodulin blood pressure drug. Read More
Democrats grilled industry representatives on drug pricing Tuesday at a Senate health committee hearing on reauthorizing the FDA’s user fee programs. Read More