Proposed rule issued in March 2010 requires ‘major statement’ on a drug’s side effects in ‘a clear, conspicuous, and neutral manner’ for TV and radio ads. Bill would mandate a final rule within six months.
The US Food and Drug Administration’s 12 year delay in issuing a final rule on the presentation of the “major statement” of a drug’s side effects and contraindications in television and radio advertisements has gotten the attention of Congress.
Five members of the House, led by Rep. Abigail Spanberger, D-VA, introduced a bill, Banning Misleading Drug Ads Act,...
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.
