![appily definition appily definition](https://www.ontocollege.com/wp-content/uploads/2019/11/fafsa.png)
![appily definition appily definition](https://support.sonus.net/download/attachments/74580936/14.3%20Application%20ID%20Def%20Selection.png)
The IND is the means through which the sponsor technically obtains this exemption from the FDA.ĭuring a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. Physician Request for a Single Patient IND for Compassionate or Emergency UseĬurrent Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines.Emergency Use of an Investigational Drug or Biologic.
APPILY DEFINITION MANUAL
Manual of Policies and Procedures (MaPPs).Laws, Regulations, Policies and Procedures.