Submissions go to one of two addresses: OMORs, for changes or additions to monograph formulations and indications, go to the CDER NextGen Portal, and data, information and public comments on proposed or interim final orders go to OTC Monographs@FDA.
Two down and three to go for industry guidances required from the US Food and Drug Administration for using the overhauled OTC monograph after publication of a draft guidance on submitting monograph change proposals and other requests in the only accepted format, electronic.
The agency’s Center for Drug Evaluation and Research on 28 September announced the draft guidance to be published in...
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
Children and young adults will in future learn more about responsible self-care, including when it is appropriate to see a pharmacist, specific instructions for dental health and information about health risks associated with smoking, vaping, and other nicotine products such as nicotine pouches.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
