FDA Warns Supplement Maker For Misbranding, Procedural Violations
The FDA warned supplement manufacturer Sanapac for GMP violations, adulterated products and misbranding following two inspections in late 2016. Source: Drug Industry Daily
PTAB Throws Out United Therapeutics Remodulin Patent in Win for SteadyMed
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.…
Democrats Lobby for Price Transparency as Senate Continues User Fee Debates
Democrats grilled industry representatives on drug pricing Tuesday at a Senate health committee hearing on reauthorizing the FDA’s user fee programs. Source: Drug Industry Daily
FDA Cites Gordon Laboratories Over Supplier Evaluations, Other Violations
Drug manufacturer Gordon Laboratories received a Form 483 from the FDA for labeling problems, written procedure issues and insufficient analyses of raw materials. Source: Drug Industry Daily
Indian Regulators to Fast-Track WHO-Approved Combination Products for HIV, Hepatitis
India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Source: Drug Industry Daily
Judge Rules for Novartis in Zortress Patent Infringement Suit, with a Caveat
A federal judge ruled that three generics manufacturers infringed on Novartis’ patents related to its Zortress treatment, used during kidney and liver transplants. Source: Drug Industry Daily
Judge Invalidates Ampyra Patents, Clearing Path for Generics a Decade Early
Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — less than a month…
India Responds to Drug Quality Concerns with Electronic Monitoring
In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Source: Drug GMP Report
483 Roundup: FDA Cites Three Firms Over Quality, Other Violations
Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Source: Drug GMP Report
Warning Letter Roundup: FDA Flags GMP, Other Compliance Problems
The FDA has targeted several API manufacturers, finished drug manufacturers and supplement makers over GMP and other compliance issues. Source: Drug GMP Report
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