FDA Review posts the Federal Register notices for the week ending 10/26/2018.
FDA accepts for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previ...
An FDA Advisory Committee delivers a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all new diabetes drugs.
Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Product Labeling; Medication Guide Requi...
Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Azar says that HHS is ...
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Federal Register notice: FDA makes available a draft guidance entitled Biopharmaceutics Classification System-Based Biowaivers that was prepared by th...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...