Selected article for: "approval process and drug approval"
Author: Van Norman, Gail A.
Title: Expanding Patient Access to Investigational New Drugs: Overview of Intermediate and Widespread Treatment Investigational New Drugs, and Emergency Authorization in Public Health Emergencies
  • Document date: 2018_6_25
    • ID: 58ta20fg_12
    Snippet: Before marketing, manufacture of the drug for clinical studies is nearly an "all cost" proposition for the commercial entity; the drug cannot be marketed to cover its costs. Thus, companies generally only manufacture sufficient quantities (plus a small margin) to cover the requirements of clinical studies, rather than devote resources to manufacturing large quantities of a drug which has a <10% chance of ever making it to market (1, 2) . The FDA .....
    Document: Before marketing, manufacture of the drug for clinical studies is nearly an "all cost" proposition for the commercial entity; the drug cannot be marketed to cover its costs. Thus, companies generally only manufacture sufficient quantities (plus a small margin) to cover the requirements of clinical studies, rather than devote resources to manufacturing large quantities of a drug which has a <10% chance of ever making it to market (1, 2) . The FDA approval process begins with the filing of an investigational new drug (IND). Making the drug available to groups or classes of patients who might then deplete the supply of drug for clinical studies could compromise the very research that would more completely disclose a drug's risks and benefits; thus, it could possibly impede full market approval that would make the drug more widely available.

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