With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.
The US Food and Drug Administration’s objections to two television ads for Eli Lilly and Company’s migraine drug Emgality (galcanezumab-gnlm) were so quickly quelled that the agency posted its untitled letter and a close-out letter at the same time. It is the first time the Office of Prescription Drug Promotion has posted these letters simultaneously.
On 13 December, OPDP sent an untitled letter to Lilly stating that two of its direct-to-consumer broadcast TV ads...
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.
