Office of Prescription Drug Promotion is adding a five-day screening period to its review of core prescription drug launch materials to determine if they are actually core promotions with all necessary information. Companies can decide whether to resubmit materials deemed non-core or have FDA go forward with a non-core launch review.
In an effort to provide more timely review of core prescription drug launch materials, the US Food and Drug Administration is adding a five-day screening period to the review process to make sure companies have submitted the appropriate information.
Susannah O’Donnell, review team leader in the Office of Prescription Drug Promotion, explained in a webinar that during the screening period, the agency will confirm that a submission is complete...
Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.
Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
