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The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies, and all for data integrity issues. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
The FDA has issued final guidance for generics makers on making formal requests for information, including on topics still under agency consideration. Read More
United Therapeutics has agreed to grant Sandoz a nonexclusive license to manufacture and sell a generic version of its hypertension drug Remodulin beginning in 2018, putting an end to ongoing patent litigation. Read More
The FDA’s new team-based inspection program is starting to take shape with a steering committee led by high-ranking FDA officials and three subgroups. Read More
The FDA’s new proposed team-based inspection program completed initial inspections in its ongoing pilot and was deemed a huge success that helped investigators plan better inspections. Read More
The Federal Trade Commission is taking drugmakers to task for tweaking products to maintain exclusivity and block generic competition, warning the practice — known as product hopping — may violate antitrust laws. Read More
The Patent Trial and Appeal Board has invalidated a patent for Novartis’ multiple sclerosis drug Gilenya, in one of the first successful uses of the inter partes review process by generics drugmakers. Read More
U.S. companies taking new biologicals to 11 Pacific Rim nations would get no more than eight years of marketing exclusivity — four less than what they enjoy in the U.S. — under a trade deal agreed to by all 12 countries. Read More
A British charity is pledging roughly $154 million over the next five years toward research into treatments and diagnostics to improve cancer survival. Read More
The FDA is warning healthcare providers and patients not to use sterile drugs made by an Oklahoma compounder after the firm refused to cease sterile operations following a failed inspection — the latest in a stream of safety alerts, warning letters and Form 483s having to do with compounders’ sterility practices over the past year. Read More