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Updates on the Bioequivalence Studies for Drugs Submitted to Under an ANDA Lin Zhang
April 08, 2022
From time to time, the Food and Drug Administration (FDA) offers a lot of updates to its materials and practices, and any person involved with the industry needs to stay alert for new releases, educational events, and training.
A Brief Overview of the FDA Bioresearch Monitoring (BIMO) Program Lin Zhang
April 08, 2022
The U.S. Food and Drug Administration (FDA) held a webinar on the Bioresearch Monitoring program (BIMO) last month (2/16/2022).
A Universal Vaccine Against All Variants of COVID and SARS Lin Zhang
March 30, 2022
The Covid-19 pandemic changed a massive influence on human life around the world and led to many negative consequences in terms of global health, tourism, economics, and many other things.
FDA Stops Two COVID-19 Rapid Diagnostics Tests Lin Zhang
March 01, 2022
The coronavirus (COVID-19) pandemic has been around for more than two years. While in many ways the world is returning to normal, the wave of Omicron and continued cases of COVID-19 still need to be addressed.
The Impact of the Regulatory Science Summit 2022 Lin Zhang
February 28, 2022
The UCSF-Stanford Center of Excellence in Regulatory Science Innovation or CERSI is known for offering yearly summits focused on academia, biomedical industry, and regulatory affairs.
An Introduction to FDA Clinical Investigator Training Course Lin Zhang
January 17, 2022
The U.S. Food and Drug Administration (FDA) held a Clinical Investigator Training Course or the CITC last month (12/7-8/2021). This course has been conducted for over ten years.
Where Are the Oral COVID-19 Vaccines Stand Now? Lin Zhang
December 17, 2021
The novel coronavirus, SARS-CoV-2, has led to an unprecedented international health crisis and is continuing its spread across the world, with more than 218 million confirmed cases of COVID-19, including more than 4.5 million deaths, reported to the WHO a
From Pegan Diet to Functional Medicine and Botanic Remedy Lin Zhang
December 17, 2021
There are many different diets offered today. A Mediterranean-style diet has been widely studied, and a new concept is the so-called pegan diet, which is combined paleo and vegan two words...
Electronic Drug Registration and Listing (eDRLS) Lin Zhang
December 02, 2021
Last month (October 13, 2021), the Food and Drug Administration (FDA) held a conference that is part of the CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI) series.
Recent Progress of Pharmaceutical Industry Lin Zhang
November 22, 2021
2021 has been a wild year for the world, and the pharmaceutical industry as well. There have been significant developments in the past few months that have changed the state of the industry...