Abstract

REGULATORY REQUIREMENTS FOR DRUG, DEVICE AND BIOLOGICALS OFCOMBINATION PRODUCTS AS PER USFDA GUIDELINES

*R. Lancyjenifer and Dr. N. Senthil Kumar

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Abstract

Regulatory requirements for Drug, Device and Biologicals of Combination Products as Per USFDA Guidelines All healthcare products in the pharmaceutical industry are divided into three categories: drugs, devices, and biologics, and each is governed by its own regulatory authority. In the current scenario, the advancement of science and technology has led to the invention of innovative novel products in the healthcare system for better diagnosis and treatment of diseases. Advancement of these novel technologies has led to a blurring of traditional lines of separation between healthcare products, resulting in the existence of combination products. When opposed to individual products, combination products presenta host of regulatory and review issues. When opposed to single-entity products, combination products face a host of regulatory and review issues. In this thesis we have describe the regulations for registration of combination products in US and their regulatory considerations for identification, jurisdiction and review, premarket activities, applicability of Good Manufacturing Practices (GMPs) and post marketed requirements, e-CTD submission, clinical trial guidance document, and adverse event reporting, inspection and enforcement. Regulatory challenges and combination product requirements in accordance with FDA guidelines.

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