Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
FDA finalized guidance to help drug applicants know when they should submit an abbreviated new drug application (ANDA) or a 505(b)(2) application for their products.
In a final guidance document released Thursday (May 9), FDA lays out ways for sponsors of over-the-counter (OTC) topical drugs to conduct in vivo absorption trials that will help the agency determine whether a product is eligible to be included in OTC monograph.
Senate health committee ranking Democrat Patty Murray (WA) sent letters to three duodenoscope makers -- Olympus, Pentax and Fujifilm -- asking about their plans to respond to FDA’s findings that the number of high-concern organisms found on reprocessed duodenoscopes is nearly 2.5% more than what the agency originally reported back in 2018.
FDA on Thursday (May 9) finalized guidance that aims to help sponsors evaluate reproductive toxicity related to embryo-fetal development (EFD) for anticancer drugs, and to help sponsors figure out what labeling they should use to minimize the potential risk to a developing embryo or fetus.
FDA issued two draft guidance documents that lay out ways for drug makers to design clinical lactation studies and leverage real-world data to gauge the effects of pending and agency-approved therapies on pregnant or nursing women.
FDA has reversed policy and now says it will allow sponsors to use non-U.S.-licensed reference biologics in studies to support biosimilar interchangeability.
The government and major lobby groups oppose FDA’s biologic naming convention, which says that all new biologics, biosimilars and interchangeable biosimilars must have a nonproprietary name followed by a non-meaningful suffix.
The head of FDA’s biologics staff said she is not a fan of the agency’s biologics and biosimilars naming convention but that she understands the rationale behind it -- chiefly, a need to bolster active pharmacovigilance and to help distinguish between small molecule drugs and biologics.
A bipartisan group of senators introduced a bill that would raise the minimum age to purchase tobacco to 21.
Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests.
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