Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.
The pharmaceutical and medical device industries appear to be making headway in convincing the US FDA to narrow a final rule regarding the evidence the agency considers in determining how a manufacturer intends its product to be used, including whether it is intended for off-label use.
The agency announced that it is proposing to delay indefinitely the rule's implementation. FDA has already delayed implementing the rule...
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.
