In Brief
EWG slams FDA sunscreen oversight; NARB stays the course in Healthy Directions case; AHPA presses FDA on NDI ID guidance; CRN comments on “chemically altered” NDIs; and Desert Rose products lack full labels.
Learn what's happening at the US FDA. On the go.
More from Marketing & Advertising
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Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
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AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says.
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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.
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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
• ByJoint 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.
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Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
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The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
