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.
Two public health groups are upset over FDA's recent decision to terminate the agency's only food advisory committee, with the Center For Science in the Public Interest calling the decision “further evidence of the low value this administration places on independent scientific advice.”
FDA is adopting a risk-based enforcement approach for regulating certain categories of homeopathic drug products that are marketed without FDA approval, the agency announced through draft guidance published on Monday (Dec. 18).
FDA Commissioner Scott Gottlieb announced Friday (Dec 15) the agency's intention to work with the U.S. Pharmacopeial Convention to develop standards for drugs that FDA has highlighted as off-patent, off-exclusivity and without generic competition.
FDA on Friday (Dec. 15) published guidance for sponsors of targeted therapies, including how to identify patients for clinical trials and how to present the benefits and risks of such therapies.
FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).
FDA Commissioner Scott Gottlieb on Monday (Dec. 4) announced the agency will establish a regulatory framework for how it regulates nontraditional manufacturers of 3D-printed medical devices.
Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.
The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition.
Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb’s idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval.
FDA and CMS will increasingly work together on simultaneous diagnostic test reviews, a move that FDA Commissioner Scott Gottlieb told lawmakers Thursday (Dec. 7) could serve as “a powerful incentive” for more sponsors of diagnostic tests to voluntarily go through the FDA approval process.
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