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portada Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
Type
Physical Book
Illustrated by
Publisher
Author
Language
English
Pages
26
Format
Paperback
Dimensions
28.0 x 21.6 x 0.1 cm
Weight
0.09 kg.
ISBN13
9781533692023
Categories

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

Penny Hill Press (Illustrated by) · Createspace · Paperback

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers - Penny Hill Press ; Food and Drug Administration

New Book Imported to South Africa
Delivery: 24 Aug - 07 Sep Shipping: 16 to 20 business days.
R 452
R 452

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Synopsis "Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers"

This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA's regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009. Since 2009, FDA has received a number of questions concerning implementation of the regulations. As a result, FDA is providing guidance in a question and answer format, addressing the most frequently asked questions. In a separate guidance, FDA provides answers to questions concerning the implementation of the regulation on charging for investigational drugs under an IND (21 CFR 312.8). Also in a separate guidance, FDA describes Form FDA 3926 (Individual Patient Expanded Access-Investigational New Drug Application (IND)) and the process for submitting expanded access requests for individual patient INDs

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