As sponsors push for more access to physicians, payers hope to be able to gather more pre-approval information about drugs – like they now can with devices – for budgeting and patient access.
Payers want to attend FDA pre-submission meetings with drug sponsors to help better gauge pricing and utilization post-approval. The change, which the agency's device center recently adopted, could be one way for FDA to deal with some industry concerns about off-label communications.
Humana Inc. VP-Federal Affairs Douglas Stoss and others asked during FDA’s two-day public hearing on off-label communications that payers...
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.
