What is the FDA Drug Approval Process?

Since the 1990s, the expenditure on prescription drugs has nearly doubled, primarily attributed to the rising costs of brand-name drugs, but with notable increases in some generic medications as well. In the pharmaceutical and biotechnology sectors, sales revenue surged from $534 billion to $775 billion between 2006 and 2015. Remarkably, 67% of drug companies witnessed an expansion in their annual profit margins during this period. Furthermore, research and development spending in the drug industry grew from $82 billion in 2008 to $89 billion in 2014. Benefits of the FDA Approval

American consumers enjoy the privilege of access to the world's safest and most cutting-edge pharmaceutical system. Safeguarding their interests within this system is the Food and Drug Administration (FDA) branch of the Center for Drug Evaluation and Research (CDER) which evaluates all new drugs before they can be sold.

CDER's evaluation serves a dual purpose:

1) Preventing fraudulent practices and

2) Equipping healthcare professionals and patients with the necessary information for informed medication usage.

The center's oversight office also guarantees that both brand-name and generic drugs function as intended and that their health benefits outweigh the recognized risks.

Pharmaceutical companies who want to place drugs on the market must rigorously test their drugs before seeking approval:

• These companies submit comprehensive evidence of their drug's safety and effectiveness for its intended use to the FDA's Center for Drug Evaluation and Research (CDER).

• A dedicated team of CDER experts, including physicians, statisticians, chemists, pharmacologists, and scientists, independently reviews this data.

• If their unbiased assessment concludes that a drug's health benefits outweigh its known risks, it receives approval for sale.

While CDER doesn't directly test drugs, it does set and uphold standards for drug quality, safety, and effectiveness. Their focus is to determine whether the drug's benefits outweigh its known and potential risks for the intended patient population. It is essential to know that prior to the approval, drug companies conduct laboratory and animal tests to assess a drug's efficacy and safety, followed by a series of human trials to determine its safety, therapeutic benefits, and whether the drug works well in humans.