How do regulatory requirements impact cancer drug production?
Regulatory requirements are stringent for cancer drugs, ensuring safety and efficacy for patients. Compliance with agencies like the FDA and EMA involves extensive documentation, rigorous clinical trials, and post-marketing surveillance. These rigorous standards, while necessary, can cause delays and increase the costs of bringing new treatments to market. Navigating these regulations requires a deep understanding of the legal and scientific requirements, which can be a barrier for smaller companies and startups.
