Biological Product Applications and Submissions

Biological products are drugs that are derived from animal or other living creatures, rather than being synthetically or chemically formed. Biological products are formed from microorganisms, animals or humans, and are for this reason considered more complex than those derived from chemicals or synthetics

Under the oversight of two Acts and two Centers

When a company seeks to make biological product applications and submissions to the FDA, it has to follow strict guidelines laid out by The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), which have oversight of regulation and postmarketing surveillance of this kind of medical product.

Further, two Acts -the Public Health Service (PHS) Act and the FD & C Act govern the process of biological product applications and submissions. Hence, a company that wants to make biological product applications and submissions has to adhere to guidelines by these centers and have to also comply with the provisions of these Acts.

Indication of complexity of biological product applications and submissions

The role of two Centers and two Acts denotes the complexity of biological product applications and submissions. Another major factor that signifies the importance of these steps is the fact that biological product applications and submissions have to also satisfy manufacturing requirements. This is because unlike in the case of chemically or synthetically manufactured drugs; biological products are subject to lot of unpredictable changes after their manufacture.

Any change in the manufacturing process can impact the potency and efficacy of the end product, making the traceability of the product in the manufacturing process almost impossible. Because of this fact, the regulatory agencies monitor the manufacturing process right from the start. Satisfying each manufacturing process from start to finish is a very important determinant of biological product applications and submissions.

Biological products are drugs that are derived from animal or other living creatures, rather than being synthetically or chemically formed. Biological products are formed from microorganisms, animals or humans, and are for this reason considered more complex than those derived from chemicals or synthetics

Under the oversight of two Acts and two Centers

When a company seeks to make biological product applications and submissions to the FDA, it has to follow strict guidelines laid out by The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), which have oversight of regulation and postmarketing surveillance of this kind of medical product.

Further, two Acts -the Public Health Service (PHS) Act and the FD & C Act govern the process of biological product applications and submissions. Hence, a company that wants to make biological product applications and submissions has to adhere to guidelines by these centers and have to also comply with the provisions of these Acts.

Indication of complexity of biological product applications and submissions

The role of two Centers and two Acts denotes the complexity of biological product applications and submissions. Another major factor that signifies the importance of these steps is the fact that biological product applications and submissions have to also satisfy manufacturing requirements. This is because unlike in the case of chemically or synthetically manufactured drugs; biological products are subject to lot of unpredictable changes after their manufacture.

Any change in the manufacturing process can impact the potency and efficacy of the end product, making the traceability of the product in the manufacturing process almost impossible. Because of this fact, the regulatory agencies monitor the manufacturing process right from the start. Satisfying each manufacturing process from start to finish is a very important determinant of biological product applications and submissions.

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