CDER wants sponsors to use the NextGen Portal for electronic submission of promotional pieces to the Office of Prescription Drug Promotion, rather than sending in paper or physical media such as CDs; availability of this alternative pathway does not affect requirement for eCTD submission of some types of promotional materials starting in June 2021.
The COVID-19 pandemic is changing the way that drug sponsors submit promotional materials for US Food and Drug Administration review, and the agency is doing what it can to encourage that transition.
The Center for Drug Evaluation and Review has opened up a new pathway for drug sponsors to electronically submit promotional...
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.
