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The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiotics. Read More
European drugmakers are pressing regulators to streamline the conditional marketing authorization pathway for drugs that fulfill unmet needs, saying the current system is slower than the standard authorization process. Read More
Brazil’s Agência Nacional de Vigilância Sanitária is facing criticism from the medical device industry for hiking surveillance inspection fees as the country faces tough economic times. Read More
The European Medicines Agency has nominated Guido Rasi as its executive director, nearly one year after he was forced to resign from the position. Read More
U.S. President Obama announced Sept. 15 his intention to nominate Robert Califf as the next commissioner of the Food and Drug Administration, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. 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
Bristol-Myers Squibb has agreed to pay more than $14 million to settle charges that its joint venture in China made cash payments and provided other benefits to healthcare providers at state-owned and state-controlled hospitals in exchange for prescription sales. Read More
The FDA has reopened the comment period for draft guidance on established conditions for reporting chemical, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More