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One of the most effective ways to achieve and maintain compliance is by performing a regulatory gap analysis. This ...
In the United States, the practice of compounding is regulated under sections 503A and 503B of the Federal Food, ...
In today's globalized and interconnected world, diversity and inclusion are no longer mere buzzwords—they are ...
This blog discusses the importance of FDA's Diversity Action Plans, their impact on clinical research, and the ...
In the realm of pharmaceuticals, blockbuster drugs like painkillers and antibiotics often dominate headlines and ...
The FDA’s Off-Patent, Off-Exclusivity Drug List: Enhancing Market Competition and Drug Accessibility
One of the notable initiatives is the publication of the Off-Patent, Off-Exclusivity (OPOE) Drug List. This list ...
In this blog, we will explore what HPAPIs are, their applications, benefits, challenges, and the stringent ...
Blockchain technology, originally designed for secure digital transactions, is now finding its way into various ...
Environmental sustainability is no longer a peripheral concern but a central theme influencing industries ...
The rise of GLP-1 receptor agonists, such as semaglutide and liraglutide, marks a transformative era in the ...
In recent years, the FDA has intensified its efforts to enhance clinical diversity in medical research. This focus ...
This blog will explore what a New Animal Drug Application entails, its significance, and the steps involved in the ...
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