Aaron Lukas will be presenting at the Hatch-Waxman and BPCIA Essentials program. This is a three week program on IP basics and regulatory fundamentals relative to small molecules and biologics for brand names, generics, and biopharmas. Aaron will be discussing the following:
Rx Drugs (new drugs)
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Identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc.
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NDA (New Drug Application): definition, contents, and regulatory overview
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INDA (Investigational New Drug Application) aka “IND”
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How does it differ from an NDA?
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Accelerated approvals
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Defining eligibility criteria for accelerated approval and priority reviews
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What portions of approval submissions might FDA release and when?
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Using advisory committees in the approval process
Biologics
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How does the approval process for a biologic differ from that of a drug?
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BLA (Biological Licensing Application): application and filing
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How does a biologic differ from a drug?
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Which products require BLAs instead of NDAs?
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Why is it a “license” rather than an “approved application”?