Webpages misrepresent findings in two clinical studies to overstate efficacy of the Cushing’s syndrome drug and minimize serious risks, Office of Prescription Drug Promotion says. This is second untitled letter issued to Xeris in three years.
The US Food and Drug Administration’s Office of Prescription Drug Promotion has not cited a company for advertising violations since last June so its untitled letter to Xeris Biopharma Holdings, Inc. is notable for showing the kind of behavior that will evoke a complaint.
OPDP objected to two webpages of the consumer website for Xeris’s Recorlev (levoketoconazole) saying they make misleading statements 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.
