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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
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
AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. Read More
India’s prime minister has approved a $270 million plan to strengthen the country’s drug regulatory system, including establishing new drug testing laboratories and a training academy for regulatory and drug testing officials. Read More