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.
U.S. agencies, global regulators and stakeholders could partner to help drive down drug development costs and increase market access by harmonizing drug reviews and inspections, increasing data sharing, and developing cell lines and continuous purification technologies in a noncompetitive space, FDA and industry officials say.
FDA will take a range of actions to increase the agency’s uptake of breast implant adverse event reports and registry data, and will also make sure patients and providers are aware of the potential risks of such products by publicizing adverse events that were in a hidden database.
Following through on its obligations under the Medical Device User Fee Amendments of 2017, FDA is seeking input from patients as it formulates policies on premarket clinical studies, benefit-risk assessments and postmarket evaluation of medical devices.
FDA plans to send a legislative proposal to Congress that would subject all dietary supplements to FDA’s food enforcement authorities, even if the product does not meet the technical definition of a dietary supplement.
Public Citizen has sued FDA for not acting on the group’s petition for the agency to add boxed warnings about impulse-control and compulsive behavior on labels of all dopamine agonist drugs approved in the United States and to establish a risk mitigation program for dopamine agonists.
A group of seven state attorneys general is urging FDA to expand its proposed market removal of flavored electronic nicotine delivery systems (ENDS) to include mint- and menthol-flavored products; move premarket approval requirement deadlines for ENDS products up to 2020; and ban online sales of ENDS.
Former FDA chief Scott Gottlieb recently expressed disappointment that he ran out of time to reform over-the-counter (OTC) drug regulations and spur use of technologies that could aid in more prescription-to-OTC switches.
The House Judiciary Committee on Tuesday (April 30) voted to send four drug-pricing and competition bills to the House floor, including pay-for-delay legislation, the CREATES Act and a bill that would allow the Federal Trade Commission (FTC) to crack down on brand drug makers’ use of sham citizen petitions to delay generic drug competition.
FDA granted marketing authorization to Philip Morris International’s (PMI’s) non-combustible tobacco product, IQOS, an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol, the agency announced Tuesday (April 30).
FDA announced a slate of new food safety proposals on Tuesday (April 30), including a pilot to use artificial intelligence (AI) and machine learning to review imported foods; an effort to move towards digital food tracing technology; a promise to look into how to oversee the e-commerce food delivery system; and a public meeting to discuss all of the above with industry and state and local governments.
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