We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP deficiencies. Read More
A new study of oncology approvals shows that a majority of the candidates approved under accelerated review with surrogate endpoints lacked validation. Read More
EMA is reviewing its guidelines for Phase 1 trials in the wake of a fatally flawed French study, with an eye toward issuing proposed revisions in July. Read More
Two House Republicans are accusing the FDA of shirking its responsibility when it comes to explaining the limits of off-label promotion, leaving it up to the courts to decide the matter for it. Read More