OPDP's first enforcement letter of 2018 is notable because it comes much earlier than 2017's first, cites an opioid, and signals that the US FDA is monitoring medical meetings.
The US FDA's Office of Prescription Drug Promotion (OPDP) has taken Collegium Pharmaceutical Inc. to the woodshed in the office's first untitled letter and tangible enforcement action of 2018, which says the warning information for Xtampza ER (oxycodone extended-release) were visibly obstructed by a table and chair at an exhibit booth.
Collegium was showcasing its opioid at the American Society Health-System Pharmacists (ASHP) Summer Meetings & Exhibition 2017 in Minnesota last...
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.
