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Federal Register notice: FDA reopens the comment period for a revised draft product-specific guidance on sucralfate that appeared ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Biopharmaceutics Classification System-Based Biowaivers tha...[ Price : $8.95]
Shire files a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Eli Lillys Taltz (i...[ Price : $8.95]
FDA accepts for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for...[ Price : $8.95]
An FDA Advisory Committee delivers a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all n...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Product Labeling; Me...[ Price : $8.95]
Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Az...