Referencing opioids and suicidal thoughts is not sufficient, US regulators say; letter comes as Orexigen has seen an upsurge in Contrave prescriptions.
FDA's Office of Prescription Drug Promotion has admonished Orexigen Therapeutics Inc. for failing to include important risk information in a television advertisement for its obesity drug Contrave (naltrexone/bupropion) and for placing other important risk information solely in the visual portion of the promo.
The agency's May 18 untitled letter to Orexigen says the ad includes the statement "Do not take with...
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.
