FDA is having trouble meeting its internal goal of 45-day reviews for core launch materials due to complex issues that have required medical review division consultations, Office of Prescription Drug Promotion Director Abrams says.
Biopharma companies can improve their chances of getting timely FDA feedback on core product launch promotional materials through high-quality submissions and close interactions with review staff, the head of the agency's drug promotion review office said.
Tom Abrams, director of the Center for Drug Evaluation and Research's Office of Prescription Drug Promotion (OPDP), acknowledged industry concerns...
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.
