Future guidances may address information on healthcare sites and individual influencers and endorsers. ‘It is a difficult time to make any predictions about the timing of guidance,’ but the agency is looking at these issues, CDER deputy center director Grail Sipes tells FDLI conference.
It’s been six years since the US Food and Drug Administration issued draft guidances on the use of social media to provide information about prescription drugs, and stakeholders are eager to know when the agency will be providing further advice.
FDA’s Grail Sipes, deputy center director of the Center for Drug Evaluation and Research, told the Food and Drug Law...
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.
