Name: Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers (en Inglés)
Price: 68475.00 COP
Availability: InStock
Author: Penny Hill Press ; Food and Drug Administration
ISBN: 9781533692023

portada Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers (en Inglés)

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers (en Inglés)

Formato

Libro Físico

Ilustrado por

Penny Hill Press

Editorial

Createspace

Autor

Penny Hill Press ; Food and Drug Administration

Idioma

Inglés

N° páginas

Encuadernación

Tapa Blanda

Dimensiones

28.0 x 21.6 x 0.1 cm

Peso

0.09 kg.

ISBN13

9781533692023

Categorías

Investigación médica

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers (en Inglés)

Penny Hill Press (Ilustrado por) · Createspace · Tapa Blanda

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Reseña del libro "Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers (en Inglés)"

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