Regulatory Authorities and Applications

Regulation is a governmental agency that regulates businesses in the public interest, which ensures access to safe, quality-assured, and affordable medical products. The power of regulators to grant significant benefits to members of the public and also have a role in collecting and protecting government revenue. The regulatory authorities approve the New Drug Application (NDA) to demonstrate that a drug is safe and effective for its intended use in the population studied. The drug application covers everything from preclinical data to phase 3 trial data.

Drug development timeline Fig.1 Drug development timeline (Gwen, 2018)

Introduction to Regulatory Authorities

Regulatory bodies are staffed by specialists to establish technical, safety and quality and monitor their compliance. Their duties include drafting rules, protecting consumers, adjudicating disputes and disputes, conducting hearings, and providing general administrative services. The regulatory agencies fall into three main categories: independent regulatory commissions, executive agencies, and government corporations. In the United States, examples of regulatory agencies include the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Occupational Health and Safety Administration (OSHA), etc.

Introduction to Regulatory Applications

For regulatory applications, there are two broad application categories for drugs and biologics regulated by the FDA, namely requests for authorization for clinical investigations and requests for marketing approval. The common FDA applications for drugs & biologics include Investigational New Drug Application (IND) and New Drug Application (NDA). The IND application falls into the first category, which is the launching point for clinical investigations in the United States. The goals of the IND submission are to ensure the rights and safety of clinical trial participants. The NDA is a formal application made by a sponsor to market a new drug in the United States and regulated by FDA’s Center for Drug Evaluation and Research (CDER). The purpose of the NDA is to provide sufficient evidence to support the safety and efficacy of the drug and to show that the benefits of using the drug outweigh the risks. Besides, there are other FDA applications, and it is important to understand the different types of drug applications and when each application is necessary.

Reference

  1. Zornberg, G., n.d. Regulatory issues. Essential CNS Drug Development, pp.14-30.
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