【實用書籍app】IND/NDA Booklet|最夯免費app-綠色工廠好玩App

In US, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The Investigational New Drug (IND) and New Drug Application (NDA) applications are the vehicles through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US. 21 CFR Part 312 and 314 contain regulations applied to conducting clinical trials, working with FDA, applying for drug approval and other related topics.

The IND/NDA booklet App presents the regulations for IND and NDA in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a convenient information and reference tool for all people working in pharmaceutical and biotech industry.

Keywords : Investigational New Drug, IND, New Drug Application, NDA, drug approval, FDA, Regulation, Regulatory