Agency says superimposed text about risks and efficacy is overshadowed by "attention-grabbing before-and-after photographs" of patients treated with the seborrheic keratoses treatment.
Aclaris Therapeutics Inc.'s video advertisement for the seborrheic keratoses drug Eskata (hydrogen peroxide) drew a reprimand from the US Food and Drug Administration for failing to include risk information and misrepresenting the efficacy of the treatment.
The video features an interview with a physician, identified as a paid spokesperson for Aclaris, who makes claims about the...
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.
