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Attorneys general from a dozen states have filed a lawsuit against the FDA over its Risk Evaluation and Mitigation Strategies (REMS) for the abortion pill, mifepristone, arguing that the restrictions are not necessary and create burdens for patients. Read More
The FDA will soon announce a new pilot program to help developers of gene therapies for rare diseases get their treatments approved faster, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), at the agency’s Rare Diseases Day 2023 virtual public meeting on Monday. Read More
The FDA should move more quickly to withdraw its approval of drugs granted Accelerated Approval (AA) when negative confirmatory trial data emerge, said members of a research team that studied cancer patients treated with AA drugs. Read More
The FDA outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance. Read More
HHS has published a subset of its semiannual rulemaking agenda for 2023, outlining those planned rules – including several from the FDA – that are likely to have a significant economic impact for some small entities.
ANDA applicants should submit a request for a PSG teleconference within 60 days after publication of a new or revised PSG so that the FDA can provide timely feedback, the agency said. Read More