Drug Development

Each year many new prescription drugs are approved by the Food and Drug Administration (FDA). The process of developing and bringing new drugs to market is important for primary care physicians to understand. A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The process starts with preclinical testing. For drugs that appear safe, an investigational new drug application is filed with the FDA. If approved, clinical trials begin with phase 1 studies that focus on safety and pharmacology. Phase 2 studies examine the effectiveness of the compound. Phase 3 is the final step before submitting a new drug application (NDA) to the FDA. An NDA contains all the information obtained during all phases of testing. Phase 4 studies, or postmarketing studies, are conducted after a product is approved. Recent changes in legislation have streamlined the approval process. Critics contend that these changes have compromised public safety, resulting in the need to recall several products from the market. Proponents claim that changes in the approval process help patients with debilitating diseases, such as acquired immunodeficiency syndrome, that were previously denied critical medication because of bureaucratic regulations.

The worldwide market for medication disclosure in pharmaceuticals came to about $25.0 billion in 2013. This market is relied upon to reach $29.6 billion in 2014 and $79.8 billion in 2019, with a compound yearly development rate (CAGR) of 22.0% for the time of 2014 to 2019.

 

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