Abbott Laboratories and its spin-off AbbVie agree to pay $25 million to resolve allegations that they used kickbacks and off-label marketing and promo...
FDA inspects a Minnesota medical center and finds violations that subjected unwitting patients to dangerous and unethical human testing, according to ...
FDA approves a Jazz Pharmaceuticals supplemental NDA to revise labeling for Xyrem (sodium oxybate) oral solution to include an indication to treat cat...
FDA Review posts the Federal Register notices for the week ending 10/26/2018.
Federal Register notice: FDA reopens the comment period for a revised draft product-specific guidance on sucralfate that appeared in a 10/20/2017 noti...
Federal Register notice: FDA makes available a draft guidance entitled Biopharmaceutics Classification System-Based Biowaivers that was prepared by th...
Shire files a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin 25% [albumin (human...
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Eli Lillys Taltz (ixekizumab).