EMA Birth Control Safety Review Shows PRAC’s Clout, Concern About Newer Products
The Pharmacovigilance Risk Assessment Committee is assessing whether use of third- and fourth-generation combined oral contraceptives should be limited to women who cannot take other birth control pills; this is the ninth group of drugs PRAC has been asked to review.
You may also be interested in...
EMA’s plans for access to clinical trials data not set to be ready until well into 2014.
EMA doesn’t suspend, but warns on Ariad’s leukemia drug Iclusig for potential blood clots, while saying combined hormonal contraceptives’ benefit outweighs their risk.
The EMA has rejected Pfizer’s tofacitinib for the second time on safety grounds and Otsuka’s delamanid due to a short trial length.