Updates on the Bioequivalence Studies for Drugs Submitted to Under an ANDA
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.
April 8, 2022
by Lin Zhang
A Brief Overview of the FDA Bioresearch Monitoring (BIMO) Program
The U.S. Food and Drug Administration (FDA) held a webinar on the Bioresearch Monitoring program (BIMO) last month (2/16/2022).
April 8, 2022
by Lin Zhang
A Universal Vaccine Against All Variants of COVID and SARS
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.
March 30, 2022
by Lin Zhang
FDA Stops Two COVID-19 Rapid Diagnostics Tests
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.
March 1, 2022
by Lin Zhang
The Impact of the Regulatory Science Summit 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.
February 28, 2022
by Lin Zhang
An Introduction to FDA Clinical Investigator Training Course
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.
January 17, 2022
by Lin Zhang
Where Are the Oral COVID-19 Vaccines Stand Now?
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
December 17, 2021
by Lin Zhang
From Pegan Diet to Functional Medicine and Botanic Remedy
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...
December 17, 2021
by Lin Zhang
Electronic Drug Registration and Listing (eDRLS)
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.
December 2, 2021
by Lin Zhang
Recent Progress of Pharmaceutical Industry
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...
November 22, 2021
by Lin Zhang
How Much Money Do Pharmaceutical Companies Really Make From COVID-19 Vaccines?
The COVID-19 pandemic led to widespread effects across the world, leading not only to economic challenges but also to advancements in medicine and pharmaceutical development.
October 28, 2021
by Lin Zhang
Advancing Generic Drug Development to Approval
The FDA continuously works to change and improve their work, including the work done with generic drugs. Last month, September 21-22, 2021, the Food and Drug Administration (FDA) hosted a workshop...
October 22, 2021
by Lin Zhang