BLOO7 schreef op 12 augustus 2020 10:58:
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Dit is inderdaad de deadline.
Alles over PRV
Gilead had er 80 miloen dollar voor over.
www.gilead.com/news-and-press/press-r...19 augustus
www.raps.org/regulatory-focus/news-ar...VIII. PRIORITY REVIEW DESIGNATION
An application for a drug will receive priority review designation if it is for a drug that treats a
serious condition and, if approved, would provide a significant improvement in safety or
effectiveness. In addition, specific statutory provisions provide for priority review for various
types of applications, described in section IV. A priority designation is intended to direct overall
attention and resources to the evaluation of such applications. This section describes the
qualifying criteria and the features of priority review designation. Appendix 1 describes the
process for priority review designation.
www.fda.gov/media/86377/downloadFilgotinib voldoet aan beide voorwaarden.
Ik kan geloven dat Abbvie dat niet ziet zitten.
Hup Gala Hup