HHS blog post details activity of US FDA's Office of Prescription Drug Promotion during a year in which the office has only issued one enforcement letter, continuing a downward trend.
The Department of Health and Human Services (HHS) is spotlighting the oversight of prescription drug advertising in a year when the US FDA's Office of Prescription Drug Promotion (OPDP) could set a record low for enforcement letters issued.
A May 30 HHS blog post features a video with Mike Sauers, a staff supervisor for OPDP's advertising...
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.
