Revised draft guidance about scientific information on unapproved uses (SIUU) of medical products is “impermissibly paternalistic and overly restrictive of scientific speech,” MIWG says.
The US Food and Drug Administration’s revised draft guidance on scientific communications to health care providers about a medical product's unapproved uses did not dampen industry’s decade-long objections to its regulation of such speech.
The Medical Information Working Group, comprised of nine pharma companies, said the guidance exceeds the statutory and constitutional limits on...
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.
