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 on Thursday (Dec. 7) took steps to fulfill the digital health provisions in the 21st Century Cures Act by issuing a suite of guidances that reveal which clinical decision support (CDS) tools won't be considered devices.
FDA last week approved the first medical device cleared for use with the Apple Watch following a 19-month review process largely due to the complexity and potential risk of the product's software, which can interpret diagnostic tests without any physician involvement.
FDA published final guidance Monday (Dec. 4) aimed at helping CMS determine which investigational devices to cover by streamlining the categorization of investigational device exemption (IDE) products -- completing a process launched in 2015 through a Memorandum of Understanding (MOU) between FDA's device center and CMS' Coverage and Analysis group (CAG).
A recently released draft guidance outlining the potential expedited pathways available to gene therapy sponsors assuaged concerns that therapies promising solely durable, rather than permanent, changes in a patient may not be eligible for the 21st Century Cures-created Regenerative Medicine Advanced Therapy (RMAT) designation, according to a new blog from attorneys at Hogan Lovells.
FDA's biologics center will encourage flexible clinical trial designs for regenerative medicine by considering trials that incorporate adaptive designs, enrichment strategies or novel endpoints.
One of FDA's newest regenerative medicine advanced therapies (RMAT) draft guidances provides the regenerative medicine industry with much-needed regulatory clarity and consistency, according to the head of lobby group Alliance for Regenerative Medicine (ARM), but some questions remain.
FDA on Thursday (Nov. 30) approved the first once-monthly buprenorphine injection -- a drug-device combination product -- to be used to treat moderate-to-severe opioid use disorder (OUD).
FDA will set out in guidance a policy of allowing complex generics and the brand product they are copying to have different labels so long as those changes reflect solely design differences, Commissioner Scott Gottlieb said this week.
FDA is forming a Nicotine Steering Committee composed of agency leaders tasked with revamping FDA's policies surrounding nicotine replacement therapy (NRT) products, FDA Commissioner Scott Gottlieb, drug center chief Janet Woodcock and Center for Tobacco Products Director Mitch Zeller wrote in a Wednesday (Nov. 29) FDA Voice blog.
FDA has fulfilled a promise it first made in 2016 to list patent submissions dates in the Orange Book, making it easier for generic companies to discern whether the patent will trigger certain required Hatch-Waxman steps.
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