Sanofi agrees to pay $11.5m and enter new corporate integrity agreement to mitigate risk and establish independent charity budget.
Sanofi US is the tenth drug maker to reach a settlement with the US Department of Justice to resolve allegations that it paid kickbacks to Medicare patients through a copy assistance foundation, and like most of the other companies it agreed to establish a risk assessment process as part of a corporate integrity agreement.
The settlement shows how companies are resolving government investigations of their charitable relationships, which has been a primary focus of...
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.
