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FDA new regulation: Improving pharma product security through serialization and track & trace Muhammad Asim Niazi
March 01, 2022
The FDA in the United States is the regulator for Pharmaceutical drugs and plays various roles in the human health field. Among them, the most critical is the safety of pharma products.
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.
Boost for Dry Eye Disease Treatment As FDA Approves Generic Drug SHEM OIRERE
February 28, 2022
The Federal Drugs Agency (FDA) has approved the Abbreviated New Drug Application for the making of Cyclo-sporine Ophthalmic Emulsion 0.05%, the first generic version of AbbVie Inc's Re-stasis. (1)
Fighting Against COVID-19: Summary of Key Products PharmaSources/Recollect
February 22, 2022
Since the outbreak of COVID-19 in 2019, many kinds of COVID-19 vaccines, COVID-19 preventive drugs and COVID-19 therapeutic drugs have been approved worldwide.
AbbVie's performance in 2021: a new high in total revenue, with the sales volumes of Hu-mi-ra topping USD 20 billion PharmaSources/Yi
February 22, 2022
On February 2, AbbVie announced its performance in the fourth quarter and full year of 2021, representing an annual revenue of USD 56.197 billion (+22.7%) and R&D investment of USD 7.084 billion (+8%).
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.
FDA changes Hepatitis C Devices Categorization SHEM OIRERE
December 17, 2021
To Support Global efforts to test and treat chronic hepatitis C has received a major boost from the Food and Drug Administration (FDA) after the US-based regulator issued a final order for the reclassification...
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.
Analysis on the Layout of Innovative Drugs in China and Globally PharmaSources/Zhulikou431
October 27, 2021
Recently, there is a saying in the pharmaceutical industry: not all innovative drugs have a future. This saying reminds me of the lyrics - wild lilies also have spring.
Advancing Generic Drug Development to Approval Lin Zhang
October 22, 2021
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...

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