TRENDS IN US FDA BIOLOGICAL LICENSE APPROVALS OVER LAST 5 FYs

ISBN-13: 9786204183787 / Angielski / Miękka / 72 str.

Hemanth Sai Tarun Sitha Ram K; Koushik Yetukuri; Rama Rao Nadendla

Opis

The discovery of novel biological drugs is significant for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as a potential candidate is one way to congregate this important goal. Systematic investigation and comprehensive analysis of approved drugs could provide valuable insights into trends in the discovery and may contribute to further discovery of newer biological drugs systematically. Food and drug administration (FDA's) Center for Biological Evaluation and Research (CBER) every year summarizes novel drugs, some of which are truly innovative and help in advancing clinical care. This study was conducted to find trends in Biological drug approvals by FDA in the last 5 Fiscal Years (FY. Awareness of these new Biological drugs amongst the primary care physicians is also crucial as they have been prescribing these agents in the past. In this cross-sectional study, we collected, surveyed, and analyzed Biological drugs approved by the U.S. Food and Drug Administration (USFDA) from the year 2016 till 2020 identified from the online database of FDA.

O autorze

K, Hemanth Sai Tarun Sitha RamHEMANTH SAI TARUN SITHA RAM. K Studying Master of Pharmacy In the Department of Pharmaceutical Regulatory Affairs at Chalapathi Institute of Pharmaceutical Sciences (AUTONOMOUS), Guntur, Andhra Pradesh, INDIA. He is good communication skills and also Published Research Articles in well-known International Journals with good Impact Factors.