Category: FDA

  • FDA Orphan Drug Designation (ODD)

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    History and Background In 1983, US Congress passed the Orphan Drug Act as an amendment to the federal Food Drug and Cosmetic Act (FDC Act) to advance the development of drugs that demonstrate promise to diagnose or treat rare diseases or conditions. In 1993, FDA issued regulations in 21 CFR 316 detailing the implementation of…

  • Clinical Dose Optimization

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    In Oncology In oncology, dose finding trials started using 3+3 dose escalation/expansion to select the recommended phase 2 dose (RP2D) and determine the maximum tolerated dose (MTD) in the 1990s. The earliest treatments for cancer – cytotoxic chemotherapies – had a steep dose-response curve and limited drug target specificity. Due to the lack of available…

  • FDA Expanded Access Programs

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    History and Background Expanded Access Programs (EAP) are governed by 21 CFR 312, Subpart I and are also referred to as “compassionate use.” They are designed to allow use of investigational drugs outside a clinical trial for subjects who do not meet the requirements of active running trial(s). There are 3 types of EAP: individual…

  • Is a Pre-IND Meeting really needed?

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    If polled, most executive teams would say they don’t want to take the time to do a Pre-IND meeting before submitting an initial investigational new drug (IND) application. I get it, it takes time, and time is money. But consider it can take MORE time to get your IND through the Food and Drug Administration…