FDA's Office of Prescription Drug Promotion issues only its third letter of 2016, although it hopes to cast wide net by targeting high-profile events like ASCO.
FDA's enforcement of promotional material has continued to dwindle in recent years, but while the volume has dropped, the pattern in many ways remains the same: The Office of Prescription Drug Promotion (OPDP) has just cited a display from the American Society for Clinical Oncology (ASCO) Annual Meeting – only the office's third letter of the year.
This time, Celator Pharmaceuticals Inc. was deemed the culprit, with the agency saying a placard for 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.
