Homeopathic Divide: FDA Talks Pre-Market Approval As Industry Floats Label Changes
FDA officials point out label changes would not resolve their concerns that homeopathics, unlike other Rx and OTC drug categories, are available without pre-market approval. Stakeholders emphasize the products’ safety while suggesting changes such as more information on labels to better identify ingredients.
More from Marketing & Advertising
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.
More from Compliance
HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments
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.






