Four years after Woodcock’s famous comments, OPDP notes it is evaluating comparative claims as indicated in a recent untitled letter. DOJ is also looking at comparative claims. New FDA guidances are in the works, but it remains unknown when they will issue.
Catherine Gray, director of the US Food and Drug Administration’s Office of Prescription Drug Promotion, cleared up a question some sponsors have about comparative claims in product advertisements when she noted that the agency is, in fact, paying attention to them.
During the Food and Drug Law Institute’s 13-14 October conference on advertising & promotion for medical products, a panel moderator...
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says.
The lung cancer drug Krazati from Bristol Myers Squibb’s Mirati Therapeutics drew an FDA ad/promo untitled letter, highlighting the agency's trend of pursuing false or misleading efficacy claims, particularly when data comes from outside approved labeling.
The UK and EU pharma industry associations have defended their respective codes of practice despite alarming study results. Meanwhile, a consultation on proposals to revise the UK code received over 3,500 comments.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
