Biologics

Biologics, in the context of drug regulatory affairs, refer to a class of therapeutic products derived from living organisms or containing components of living organisms. These can include vaccines, blood and blood components, gene therapies, tissues, and recombinant therapeutic proteins. Regulatory affairs pertaining to biologics are crucial for ensuring their safety, efficacy, and quality throughout their lifecycle, from development to post-market surveillance.

Here's a breakdown of the key aspects of regulatory affairs concerning biologics:

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