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The guidance makes clear that all studies intending to use and submit such data need to have their protocols and statistical analysis plans submitted prior to initiation. Read More
This sort of action against CROs is something rarely seen from the FDA; the last occurrence was in April 2016 and involved another Indian CRO, Semler Research. Read More
Negotiations over settlements with Native American tribes are not covered by the ongoing settlement process involving state and local governmental entities. Read More
The FDA encourages sponsors of new drug and biological products to take steps to reduce uncertainties that can affect the agency’s benefit-risk assessments, in a new guidance released yesterday. Read More
Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA this week issued a 21-page draft guidance to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Read More
The House Judiciary Committee voted yesterday to advance a bill meant to stop drugmakers from engaging in anticompetitive practices, one day after marking up three separate bills that also target prescription drug prices. Read More
Both chambers of Congress voted yesterday to approve a stopgap measure funding the federal government, including the FDA, through Dec. 3, narrowly avoiding a government shutdown at midnight. Read More
Sponsors that plan to seek approval based on a single trial and confirmatory data should discuss their development program with the FDA, the agency said. Read More
The Senate is racing to vote on a stopgap measure keeping federal agencies, including the FDA, funded through Dec. 3, a critical step in avoiding a shutdown set to occur Friday. Read More
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said his center continues to experience large losses of staff during the pandemic — possibly limiting CBER’s ability to achieve its goals for next year. Read More