Agency cites video promoting Biohaven’s Nurtec ODT, which first aired on ABC’s TV show The View, for misleading comparative claims, inadequate display of risk information, and failure to submit promo for review.
Biohaven Pharmaceuticals, Inc. was rebuked by the US Food and Drug Administration for a video of TV reality show personality Khloé Kardashian promoting its migraine drug Nurtec ODT (rimegepant). It is the second time the agency has objected to a drug promotion by a member of the Kardashian family.
In an 8 March untitled letter to Biohaven, part of Biohaven Pharmaceutical Holding Company Ltd., the FDA’s Office...
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.
