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FDAs Florida District Office warns Nephron Pharmaceuticals that its Asthmanefrin is an unapproved new drug being marketed inapprop...[ Price : $8.95]
FDA warns Germans Epflex Feinwerktechnik about Quality System Regulation violations in its manufacturing of guidewire devices.[ Price : $8.95]
United Therapeutics tells FDA it supports Actelions petition asking that any generic Ventavis be approved with a nebulizer that ha...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Cl...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: ANDA Submissions Refuse-to-Receive Standards.[ Price : $8.95]
Former FDA district director John Scharmann says CDRHs plan to pilot pay-for third-party inspections in January is likely to be as...[ Price : $8.95]
Vertex Pharmaceuticals files a supplemental NDA for Kalydeco (ivacaftor) monotherapy for people with cystic fibrosis aged six and ...[ Price : $8.95]
CDER releases a draft guidance on ANDA Submissions ― Refuse-to-Receive Standards that describes what should be included in a...