Regulatory requirement for the approval of novel, nanotechnology-based biological products
Author:
Publisher
Elsevier
Reference11 articles.
1. Regulatory Affairs introduction;Green;Toxicol. Pathol.,2009
2. Guidelines for Evaluation of Nanopharmaceuticals in India, Government of India New Delhi, October 2019.
3. Generic drug approvals since the 1984 Hatch–Waxman Act;Gupta;JAMA Intern. Med.,2016
4. Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators;Holbein;J. Investig. Med.,2009
5. Predictive analysis of first abbreviated new drug application submission for new chemical entities based on machine learning methodology;Hu;Clin. Pharmacol. Ther.,2019
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