![]() While timing may vary, it generally takes 10–13 y for a new medicine to go from initial discovery to the marketplace, with clinical trials alone taking 6–7 y. These applications include not only the clinical data from the phase 1, 2, and 3 studies, but also include data on product quality, manufacturing, and animal toxicology/pharmacology. Once the range of phase 1–3 studies are complete, applicants submit a New Drug Application (NDA) for a small molecule drug or a Biologic License Application for a product produced in a biologic system, such as a monoclonal antibody. Phase 4 studies are post-clearance studies that are done to further clarify the safety profile and/or the efficacy of the drug, often in new subject groups or for related indications. ![]() Phase 3 studies are large, randomized, controlled clinical trials that establish the safety and efficacy of the drug for the desired indication and are often referred to as pivotal studies. ![]() Phase 2 studies enroll well-defined subjects with the intent to explore efficacy, establish the dose range/or regimen, and further delineate safety and tolerability. Later PK studies may involve special populations (eg, renal impairment) or explore drug–drug interactions. Phase 1 studies are intended to explore the pharmacokinetics (PK) and tolerability profile of the drug in a relatively small number of healthy volunteer subjects (or, less commonly, patients). Drug development proceeds in several phases, although these do not need to be distinct or serial. This review will give practitioners a fuller understanding of drug development for COPD and asthma.ĭevelopment for any therapeutic drug intended for marketing in the United States begins with an Investigational New Drug application that is filed with the FDA to allow studies in humans to proceed. This review will also address briefly the development of generic inhaled drugs. The purpose of this review is to describe the development of drugs for asthma and COPD intended for marketing in the United States, and to help clarify the types of well-controlled clinical investigations that are necessary for regulatory clearance. The clearance of a drug and the resulting labeling reflects the key evidence provided to and reviewed by the FDA. Even with this standard met, the FDA must weigh all of the clinical, non-clinical, and quality data (ie, chemistry and manufacturing information) for a product to determine its overall benefit/risk. Generally, this is interpreted as at least 2 pivotal trials that show clear evidence of efficacy based on clinically relevant end points of efficacy. Substantial evidence for efficacy is determined in 21 CFR 314.126 based on reports of adequate and well-controlled investigations. The FDA follows the rules and regulations set forth in the Code of Federal Regulations (CFR), which implements the Food, Drug, and Cosmetics Act. Food and Drug Administration (FDA) clearance of drugs is based on regulatory and legal standards, including the need for sponsors to provide substantial evidence for effectiveness. While clinical guidelines and individual prescribers recommend the use of products for asthma or COPD on the basis of evolving clinical data and experience, the U.S. The development of drugs for asthma and COPD in the United States involves regulatory oversight and clearance, the specifics of which are not familiar to many prescribers.
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