Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
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3/15/13%<br />
Transition probabilities 1993-2002<br />
DiMasi and Grabowski (2007a)<br />
NDAs are Filed Electronically and Can Consist <strong>of</strong><br />
as Many as 15 Different Sections:<br />
• Index<br />
• Summary<br />
• Chemistry, Manufacturing, and Control (CMC)<br />
• Samples, Methods Validation Package, and Labeling<br />
• Nonclinical Pharmacology and Toxicology<br />
• Human Pharmacokinetics and Bioavailability<br />
• Microbiology (for anti-microbial <strong>drug</strong>s only)<br />
• Clinical Data<br />
• Safety Update Report (typically submitted 120 days after the<br />
NDA's submission)<br />
• Statistical<br />
• Case Report Tabulations and Case Report Forms<br />
• Patent Information and Patent Certification<br />
• Other Information<br />
FDA Pain Points in Drug Development<br />
• Bureaucratic<br />
& slow<br />
• Not creative<br />
• Risk averse<br />
especially to<br />
innovative<br />
technologies<br />
7%
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