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.
The heads of two major dietary supplement lobbies support establishing incentives for the dietary supplement industry, including the possibility of exclusivity, but they are adamant such incentives should not mirror exclusivity as it exists in the prescription drug space.
FDA’s food center director Susan Mayne announced the agency will stay the course on its plan to have industry comply with food facility defense regulations beginning in July.
FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16).
Newly minted FDA Acting Commissioner Ned Sharpless said he will not stray far from FDA’s current goals, especially those that were laid out under former commissioner Scott Gottlieb’s leadership.
FDA took several steps towards ramping up its regulation of dietary supplements on Tuesday (April 16), when the agency launched a list of unlawful dietary supplement ingredients and sent warning letters to 11 companies for using ingredients that either do not meet the statutory definition of a dietary ingredient or for which the company had not sent in a new dietary ingredient (NDI) notification.
The generic drug and pharmacist lobbies are concerned about the burdens that could be imposed on the generic drug industry and health care stakeholders, respectively, should FDA finalize in its current form recent draft guidance that explains how sponsors can gauge the effect risk mitigation strategies have on patient access and the health care delivery system.
Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.
New findings from duodenoscope sampling studies show the number of high-concern organisms found on reprocessed duodenoscopes is nearly 2.5% more than what FDA originally reported back in 2018, the agency’s device center director announced Friday (April 12).
FDA on Thursday (April 11) finalized a decision that 28 active ingredients are not allowed to be used in over-the-counter hand sanitizers -- also known as OTC consumer antiseptic rubs -- and deferred making a decision and called for more data on three other active ingredients, including ethyl alcohol, which the agency says is the most commonly used ingredient in hand sanitizers.
Device stakeholders have another 30 days to comment on FDA’s proposal to post on its website cleared devices that demonstrated substantial equivalence to older predicate devices as part of its bid to encourage device makers to use new predicates.
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