Hahn’s communications, which go far beyond the claims a sponsor could make of an investigational product, are raising new concerns about the agency’s ability to serve as a science-based regulator during the coronavirus pandemic. HHS Secretary Alex Azar and NIAID Director Anthony Fauci have also touted the lifesaving nature of plasma donations for COVID-19, even though the treatment is still unproven.
The US Food and Drug Administration’s public emphasis on the life-saving nature of plasma for COVID-19 is raising new concerns about the agency’s ability to serve as a neutral arbiter of safety and effectiveness during the coronavirus pandemic.
Commissioner Stephen Hahn is pictured on a billboard asking people who have recovered from COVID to “help us save lives,”...
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.
