Approval process acceleration

New Drug Approval Process Fourth Edition, Accelerating Global Registrations, edited by Richard A. Guarino... 

Fast track program This program was added under the FDA Modernization Act of1997 as an extension of the accelerated drug and biologic product approval process. It was designed to facilitate development and expedite review for products that demonstrate potential or unmet medical needs in the treatment of serious or life-threatening conditions. 

Graul Al (2009) Promoting, improving and accelerating the drug development and approval processes. Drug News Perspect 22(l) 30-38... 

Guarino RA. The new drug application, content and format. In New Drug Approval Process. 4th edition. Accelerating Global Registrations. Guarino RA, ed. 2004. Marcel Dekker, Inc., New York. pp. 113-172. 

The greater control over promotional practice, under the accelerated approval process, usually places less burden on an ethical company than the post-marketing safety requirements. Promotional materials must be submitted for review before NDA approval, with the obviously desirable intention that promotion should not be any broader than the approved indication, which under these special circumstances is likely to be narrower than usual. Furthermore, the package insert should usually quantitate how narrow or broad the tolerability experience with the drug might be frequent labeling revisions and NDA supplements should be planned for. 

In practice, good NDA sponsors find that post-marketing studies lead to package insert changes much more often than withdrawal of the entire NDA. There is also no evidence, so far, that the accelerated approval process has led to any serious threat to the public health. This new reviewing practice that appears to be working well. 

Although some compounds exhibit both in vitro and in vivo antiviral activities, optimization of their pharmacokinetic and pharmacodynamic properties has presented major problems. In view of the great demand for successful anti-AIDS drugs, the U.S. FDA has approved nine drugs as Pis under the accelerated approval process. 

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