The rapid pace with which inaccurate information can spread on social media may necessitate loosening some of FDA’s regulations on sponsors to let them respond, Commissioner Robert Califf said at the J.P. Morgan Healthcare Conference. Califf also worried about how legitimate debate can undermine public confidence in FDA.
US Food and Drug Administration Commissioner Robert Califf foreshadowed upcoming agency action that might give drug sponsors more ability to push back against bad actors who make false claims about their medical products without fear of retribution from regulators for violating federal rules around direct-to-consumer advertising.
Califf, speaking 10 January at the J.P. Morgan Healthcare Conference, laid out a strong critique of direct-to-consumer advertising for medical...
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.
