PhRMA Senior Counsel Jeffrey Francer offers three-step reform approach to loosening FDA’s restrictions, beginning with the 'low-hanging fruit' of talking with payers.
FDA could relax its constraints on off-label communications by biopharmaceutical manufacturers in stages, starting with allowing broader discussions with payers and other groups making coverage decisions, the Pharmaceutical Research and Manufacturers of American and Biotechnology Innovation Organization are suggesting.
“All of this change doesn’t have to occur all at once. We think it’s useful to think about a possible...
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.
