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FDA asks members of its Ophthalmic Devices Panel whether a retinal prosthesis is likely to be safe and effective in inducing visua...[ Price : $8.95]
FDA approves a REMS including a pregnancy registry for all mycophenolate-containing drugs.[ Price : $8.95]
A Hyman Phelps & McNamara blog posting summarizes key provisions CDRH is working on after the passage of the FDA Safety and Innova...[ Price : $8.95]
Pfizer asks FDA to require applicants for generic Oxecta to use the same inactive ingredients that contribute to its safety profil...[ Price : $8.95]
Federal Register Advance notice of proposed rulemaking: FDA extends the comment period on potential changes to its regulations for...[ Price : $8.95]
Federal Register Notice: The HHS Secretary delegates authority to the FDA commissioner to determine that any clinical trial inform...[ Price : $8.95]
Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 11/28 to discuss a Janssen Therapeutics NDA for tr...[ Price : $8.95]
FDA grants priority review for a Sucampo/Takeda Pharmaceuticals sNDA for Amitiza (lubiprostone) for treating opioid-induced consti...