US FDA should apply same regulatory protections to manufacturer communications with payers about unapproved uses that agency draft guidance provides to information exchanges about investigational products, biopharma companies say.
Drug manufacturer communications to payers about off-label uses of approved products should be protected from US FDA enforcement if those uses are being actively studied or undergoing regulatory review, biopharma companies say.
In comments on FDA’s draft guidance on payer communications, industry groups and individual companies urge FDA to provide information exchanges...
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.
