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Federal Register notice: FDA makes available a draft guidance entitled Microbiological Quality Considerations in Non-Sterile Drug ...[ Price : $8.95]
FDA publishes one final and one draft guidance relating to gene therapy products.[ Price : $8.95]
FDA clears the Siemens Medical Solutions NAEOTOM Alpha improved CT imaging device, described by the agency as the first major CT t...[ Price : $8.95]
CDER drug safety operations (DSO) associate director Terry Toigo retires and, in the interim, DSO senior staff member Amy Ramanadh...[ Price : $8.95]
The 11th Circuit Court of Appeals tells a Florida federal court it erred in granting summary judgment to FDA and Jacobus over orph...[ Price : $8.95]
Bills in the House and Senate would create an emergency supply of active pharmaceutical ingredients needed to make essential gener...[ Price : $8.95]
Apellis Pharmaceuticals says it will file an NDA for pegcetacoplan, an investigational, targeted C3 therapy treating geographic at...[ Price : $8.95]
PharmaTher Holdings retains former CDER antipsychotic guru Thomas Laughren as a regulatory affairs advisor to help a depression th...