regulatory requirements

What is the Drug Approval Process for Cancer Therapies?

The drug approval process involves several stages, including preclinical research, clinical trials, and regulatory review. Preclinical research involves laboratory studies and animal testing to assess the drug's safety and efficacy. Clinical trials are conducted in phases (Phase I, II, and III) to further evaluate the drug in humans. After successful trials, a New Drug Application (NDA) or Marketing Authorisation Application (MAA) is submitted to regulatory authorities for review and potential approval.

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