House Oversight Committee members grill McKinsey global managing partner about whether the firm told FDA about its simultaneous work for opioid maker Purdue. Agency says it does not anticipate future contracts with McKinsey until investigations are completed.
A Congressional hearing on McKinsey & Company’s overlapping consulting work for Purdue Pharma L.P. and the US Food and Drug Administration leaves several questions unanswered, such as whether this will lead to any changes in FDA policies.
The House Committee on Oversight and Reform’s 27 April hearing focused on the advice McKinsey provided to Purdue and its...
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.
