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An FDA final rule will require producers of PET drugs to submit NDAs or ANDAs for their drugs starting in two years.[ Price : $8.95]
The Obama administration sends mixed signals on whether it supports legislation to permit drug importation.[ Price : $8.95]
Repligen reports mixed results from a Phase 3 clinical trial evaluating RG1068, a synthetic human secretin intended to improve mag...[ Price : $8.95]
Protalix Biotherapeutics submits an NDA for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for treati...[ Price : $8.95]
Federal Register Notice: FDA establishes a public docket to obtain suggestions on elements for an approved tobacco retailer traini...[ Price : $8.95]
FDA issues a guidance with its thinking on how PET drug manufacturers can comply with cGMP regulations.[ Price : $8.95]
The Government Accountability Office says that FDA should develop a comprehensive plan and timeline for transferring more responsi...[ Price : $8.95]
House and Senate health reform bill both support 12 years market exclusivity for branded biologics facing generic competition, but...