development plans;IND submissions;integrated summary reports;NDA and eCTD submissions;journal manuscripts;and abstracts...
. In October **** , the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company...
IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data...
. In October ****, the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company...
(interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports...
CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the...
team with outstanding safety queries, interacts with sponsor on site safety issues Reviews IND/SUSAR Safety Reports..., updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) Participates...