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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
A pair of U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act Wednesday. Read More
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More
Citing a recent federal court ruling that truthful off-label claims are protected free speech, Pacira Pharmaceuticals has sued the FDA, claiming a First Amendment right to promote its Exparel postsurgical non-opioid analgesic for unproven uses. Read More