A biologics license application is a request to distribute a biologic across states. It generally is submitted after an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) and after the appropriate studies have been conducted.

A biologics license application generally applies to vaccines and other allergenic drug products, blood products, and cellular and genetic therapies.

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The Food and Drug Administration (FDA) recently issued a draft guidance, a final guidance, a proposed rule, and two revised nominations for the bulk drug substance lists. These documents are meant to clarify the FDA’s position on compounded products.

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The Food and Drug Administration (FDA) is drafting a new regulation that enables a pharmaceutical company to register an outsourcing facility with the FDA. This regulation, called 503B, is part of the Drug Quality and Security Act. It is also issuing an associated guidance that further clarifies its position on outsourcing facilities and current Good Manufacturing Practices.

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Because of the dangers of misbranding and the associated recalls of such devices, it is important for manufacturers to have the appropriate labeling. Because the Food and Drug Administration (FDA) has some specific regulations regarding what can and cannot be included, it is important for manufacturers to know what to include and how to include it. Similarly, they should also know what cannot be included.

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