What does the FDA require from biopharmaceutical companies?

The FDA requires biopharmaceutical companies to follow current good manufacturing practices (cGMPs) to ensure that products are consistently produced and controlled according to quality standards. cGMPs encompass a range of regulations covering all aspects of production, from the raw materials and facility cleanliness to employee training and documentation. This ensures that every product produced is safe, effective, and of high quality, thereby protecting public health.

While clinical trials are an essential step in drug development, the FDA mandates their conduct to establish safety and efficacy, making the option of skipping them not viable. Pricing for drugs is influenced by many factors including market dynamics and pharmaceutical company strategies, but the FDA does not dictate pricing policies. Lastly, seeking approval from local governments does not align with the broader regulatory framework set by the FDA, which focuses on national standards rather than regional or local ones. Thus, adherence to cGMPs is a fundamental requirement that underscores the FDA's mission to safeguard public health.