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Global Medical Device Regulation: Registration Requirements
Medical devices are an unavoidable part of healthcare. Medical device development happens worldwide but not all devices are being marketed....

Corrective and Preventive Actions (CAPA) In
In pharmaceuticals research, production and marketing there may be errors from the human side or due to machine error. Despite...

Gene Therapy Applications, Regulations & Guidance
The applications of gene therapy represent a revolutionary advancement in medicine, providing hope for curing diseases instead of relying on...

Global Regulations on Nitrosamines in Pharmaceuticals
Despite the considerable efforts invested by global regulatory authorities in evaluating the safety and efficacy of drugs for their citizens,...

What Is Structured Product Labeling (SPL)?
Structured Product Labeling format is used to submit the labeling content in electronic format. It is a standard...

Hong Kong: New Drugs, Generics, Biosimilars
Hong Kong- New Drugs, Generics, Biosimilar Regulations: Hong Kong has a robust regulatory system for pharmaceuticals, overseen by...

US Agent Responsibilities & Importance For
The United States Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and effectiveness...

Global Regulation of Cultivated Meat
Cultivated meat is changing the future of food. As the global population grows and meat demand rises, traditional...