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Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should c...[ Price : $8.95]
FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing prac...[ Price : $8.95]
A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize t...[ Price : $8.95]
Researchers at the University of Cincinnati begin a new study to investigate whether widely used diabetes and weight-loss drugs co...[ Price : $8.95]
FDA denies a 2024 Aimed Alliance petition asking for a guidance on human drug importation by alternative funding programs.[ Price : $8.95]
Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell disease, following a pre-submission ...[ Price : $8.95]
FDA issues a safety alert warning that patients taking Amgens Tavneos (avacopan) for a rare autoimmune condition may face a risk o...[ Price : $8.95]
Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health...