Biologic Drug Development And Approval

All pharmaceuticals marketed in the United States, including biotechnology products, must be proven safe and effective for their intended use. The FDA requires that all recombinant proteins and other biotechnology products be produced by a manufacturer holding a certified Biologic License Establishment (BLE). The pharmaceutical company is required to collect safety and efficacy data, first in animal studies and subsequently in clinical trials. This information is submitted in a new drug application package called a Biologic License Application (BLA). The data are rigorously evaluated by FDA staff, assisted by independent experts assembled as advisory panels. New drugs are approved if their benefits outweigh risks. A schematic summary of a typical clinical trial and drug approval process is presented in Figure 2.1, Chapter 2. In the following, we will expand our discussion of key issues related to clinical trials and approval process including (1) Biologic License Establishment, (2) preclinical and clinical testing requirements, (3) FDA review and approval process, and (4) globalization or harmonization of drug approval (Figure 4.17).

Preclinical Studies

Clinical Studies

BLA review

Fermentation, synthesis large scale preparation and product characterization

Preclinical Studies

Clinical Studies

BLA review

Fermentation, synthesis large scale preparation and product characterization

° M etcouraghdhe FDA staffA petition to fda is encouraged '—^

FDA advisory committees

@ Institutional Review Board XJ FDA Review decision SubPart E (see Box 4-7)

Figure 4.17. Progression of a new molecular entity through preclinical and clinical evaluation for safety and efficacy. Preclinical and clinical study results are reviewed by FDA through several pathways, including traditional and nontraditional pathways. A majority of submitted new drug applications are approved for human use. Additional details on nontraditional clinical pathways are presented in Box 4.7. (Figure adapted from an FDA report, 1999)

° M etcouraghdhe FDA staffA petition to fda is encouraged '—^

FDA advisory committees

@ Institutional Review Board XJ FDA Review decision SubPart E (see Box 4-7)

Figure 4.17. Progression of a new molecular entity through preclinical and clinical evaluation for safety and efficacy. Preclinical and clinical study results are reviewed by FDA through several pathways, including traditional and nontraditional pathways. A majority of submitted new drug applications are approved for human use. Additional details on nontraditional clinical pathways are presented in Box 4.7. (Figure adapted from an FDA report, 1999)

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