What is the Process for Drug Approvals in Cancer Treatment?
The process for drug approvals in cancer treatment is rigorous and involves several stages. Initially, preclinical studies are conducted in laboratories and on animals to assess the drug’s safety and efficacy. If successful, the drug enters clinical trials, which are divided into three phases. Phase I trials focus on safety and dosage, Phase II on efficacy and side effects, and Phase III on comparing the new drug to standard treatments. Once these phases are completed, the drug developer submits a New Drug Application (NDA) to regulatory bodies like the FDA for approval.
