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With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. 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
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 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
Presidential candidate and Senate HELP Committee member Bernie Sanders said Friday that he plans to vote against confirming Robert Califf as the new FDA commissioner, citing Califf’s strong ties to industry. Read More
Drugmakers are urging the FDA to clarify how and why the consumer brief summary in direct-to-consumer print advertisements should differ from FDA-approved patient labeling and medication guides. Read More