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Spectrum Pharmaceuticals is on track to file an NDA for its cancer drug apaziquone by the end of this year, following agreement with the FDA on a special protocol assessment for a Phase 3 clinical trial in patients with non-muscle invasive bladder cancer. Read More
Vaccines makers should submit individual case safety reports and attachments to the Vaccine Adverse Event Reporting System using either the direct database-to-database method or the eSubmitter tool method, the FDA says. 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
Teva is voluntarily recalling 19,504 bottles of amphetamine tablets that could contain impurities, the latest in a series of recalls by the company this year. Read More
Companies planning to market a botanical drug under an NDA must be able to prove the therapeutic consistency of the product, since the potential for variation is critical, the FDA says. Read More
Companies developing drugs for rare diseases that lack alternative treatments may be able to start clinical trials without the standard toxicology studies, provided they justify the approach, the FDA says. Read More