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's final guidance on the use of emerging technology in pharmaceutical manufacturing remains largely unchanged from the 2015 draft guidance, despite the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Association for Accessible Medicines (AAM) calling for the agency to list suitable technologies and detail the criteria for being accepted into the program.
FDA Commissioner Scott Gottlieb announced Wednesday (Oct. 11) that the agency will establish a patient affairs team that will “be responsible for the coordination of certain agency-wide and multi-center projects related to patient engagement.”
During the first meeting of FDA’s Patient Engagement Advisory Committee (PEAC) on Wednesday (Oct. 11), patients and patient advocates, industry, and FDA discussed a need to craft regulatory policy around patient engagement in clinical trials and provided solutions for increasing and possibly incentivizing patient participation and retention in studies.
An FDA expert panel unanimously voted Thursday (Oct. 12) to recommend approval of Spark Therapeutics' Luxturna (voretigene neparvovec) -- a gene therapy used to treat patients with a rare form of genetically-inherited blindness -- that some analysts say could cost nearly $1 million per patient.
FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.
For the first time, FDA has awarded research grants intended to fund natural history studies of rare diseases, the agency announced Friday (Oct. 6).
The patient group behind the first-ever externally-led Patient Focused Drug Development (PFDD) meeting is now urging FDA to commit to using this data as part of the agency's review of medical products, and to transparently outline how it directs reviewers to consider the data.
Coming as FDA Commissioner Scott Gottlieb pushes to reform the clinical trial process, drug center chief Janet Woodcock rebuffed arguments by some that regulators should eliminate existing global consensus regulations on trial practices because they increase drug development costs.
FDA Commissioner Scott Gottlieb said the agency's new device pre-certification pilot program offers a “modern approach to regulation” that could be applied across the agency, including to laboratory-developed tests (LDTs).
FDA proposed Friday (Sept. 29) to extend the compliance dates for its nutrition facts regulations, citing a need to issue guidance on added sugar and dietary fiber for manufacturers to be able to successfully update their nutrition facts labels.
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