FDA Shutdown Plans For 2015: Same As 2013, But With More People
This article was originally published in The Pink Sheet Daily
'Limited activities related to user fee funded programs' will continue if Congress does not pass a short-term funding measure by Oct. 1.
You may also be interested in...
As normal operations – and normal budget worries – resume, the agency has some meetings to reschedule.
Riociguat becomes the first therapy indicated for chronic thromboembolic pulmonary hypertension in the U.S. Labeling includes Bayer’s recommended starting and maximum doses but provides the option for a lower starting dose in patients who may not tolerate the hypotensive effects, a concern for agency reviewers.
FDA cleared the single pill combining conjugated estrogens with bazedoxifene, a novel selective estrogen receptor modulator, for two indications but issued a “complete response” letter for use in vulvar and vaginal atrophy.