[Download] "Expanded Access to Investigational Drugs for Treatment Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition)" by The Law Library # eBook PDF Kindle ePub Free
eBook details
- Title: Expanded Access to Investigational Drugs for Treatment Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- Author : The Law Library
- Release Date : January 06, 2018
- Genre: Law,Books,Professional & Technical,
- Pages : * pages
- Size : 431 KB
Description
The Law Library presents the complete text of the Expanded Access to Investigational Drugs for Treatment Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018
The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.
This ebook contains:
- The complete text of the Expanded Access to Investigational Drugs for Treatment Use (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure