RFD & Pre-RFD Submissions For Combination Products In USA
The healthcare landscape is in a perpetual state of transformation, and as a consequence, there is a noticeable surge in […]
US FDA Compliance
US FDA Regulation of Nitrosamines In USA
Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked significant concern
Pharmacovigilance of Vaccines in the USA (US FDA)
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other
US FDA Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law on December 29, 2022, is a significant milestone
Medical Device Registration in USA by US FDA
The responsibility for overseeing the regulations of medical device companies involved in the production, repackaging, relabeling, and medical device registration
510(k) Registration with US FDA – Medical Device Registration in USA
Medical devices regulatory compliance is paramount to ensure patient safety and effective product performance. The 510(k) registration process, overseen by
Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD
Pharmacovigilance of Biologics in the USA (US FDA)
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from
US FDA Pharmacovigilance Requirements For Drugs in the USA
Pharmacovigilance is a cornerstone of drug regulation in the USA, playing a crucial role in ensuring the safety and efficacy