Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 6, Issue 3, 2019

Background: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new med Read More

Objective: To present an overview of import need for wound care and burn dressings in India. This article provides a complete analysis of the import-export value of wound care and burn dressings in India. It helps in preparing growth strategies, knowledge about leading players, recent developments, business strategies, and manufacturing status of the wound care and burn dressings in India. Methods: A trend analysis o Read More

Background: Biological products comprise the most complex and diverse types of drugs that are made by living cells. The use of biological products has increased significantly in recent decades and has contributed significantly to improving the efficacy of treatment in many diseases. Patent protection for pharmaceutical products, including biological products, generally expires about 20 years after development. Expiration of Read More

Objective: Medical device acceptance of patients has grown considerably in recent years. This has question the effectiveness of the current regulatory frameworks to ensure the performance, safety, and quality of new devices. This article focuses on the methodical overview on hip and knee joint replacement medical devices evaluating the procedure and proper analysis of medical device regulation in three jurisdictions Read More

Background: In today’s era, various health boosting products viz. probiotics, functional foods, dietary supplements and nutraceuticals are gaining great commercial interest. Although probiotics have traditional history of their use, their regulatory approval regimes across the globe are complicated and incoherent. Objective: The present article has been compiled to give an overview of the existing approval guidelines for Read More