Can I read ANDA Regulatory Approval Process Overview on EtoBox?
ANDA Regulatory Approval Process Overview by Shubham Sule is a document available to read on EtoBox.
What is ANDA Regulatory Approval Process Overview about?
An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to obtain FDA approval for generic drug products. The ANDA contains data to demonstrate that the generic drug is bioequivalent to an already approved brand name reference drug. If approved, the generic manufacturer can produce a lower-cost alternative to the public. The ANDA review process involves assessing the generic drug
- Author
- Shubham Sule
- Language
- EN