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Biologic Manufacturing and the FDA - Essay Example

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Biologic Manufacturing and the FDA

Biologics combined with radioactive components are considered biologics, while biologics combined with non-radioactive components are drugs. While most analyses of the U.S. Food and Drug Administration (FDA) focus on the agency's authority to decide which new treatments reach the American marketplace, the FDA plays a regulatory gatekeeper role at another key point in the biological development process. In reviewing investigational new drug applications (INDs), the FDA determines which experimental therapies, vaccines, and other biological products advance from preclinical through clinical development to the licensing phase (Mark). Biopharmaceuticals are licensed under Section 351 of the Public Health Service Act (Mark)and in specific sections of the Food, Drug and Cosmetic Act. To obtain marketing approval for a new biologic, an applicant submits a biologics license application (BLA) (Koan and Ellis). The BLA must permit agency reviewers to make four principal determinations:
The growth media falls under Federal food, Drug and Cosmetic Act (the act) and hence, controlled by the same, specifically, if the media is derived from any protein, a label stating the possibility of the media as an allergen should be stated. ...Show more


Biologics, derived from living sources (such as humans, animals, and microorganisms are complex mixtures that are not easily identified or characterized, and many biologics are manufactured using biotechnology (Koan and Ellis). In 1991, an agreement between the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) created a regulatory framework for biotechnology products (Koan and Ellis)…
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Biologic Manufacturing and the FDA essay example
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