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...
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Aug 304 min read
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...
Aug 76 min read
Microbiome Based Therapies : Regulations and Market Outlook
Microbiome-based therapies are a promising area in precision medicine, aiming to tailor treatments based on individual microbial...
Jul 265 min read
US FDA Regulation of Nitrosamines in the USA
Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked...
Jun 264 min read
Precision Medicine – US FDA Regulations and Reimbursement Policies
Precision medicine represents a transformative approach to healthcare, aiming to tailor treatments to individual patient characteristics,...
Jan 15 min read
US FDA Guidance on Registration and Listing of Cosmetic Products and Facilities under Modernization of Cosmetics Regulation Act (MoCRA)
In December 2023, the United States Food and Drug Administration (FDA) ushered in a new era for the cosmetics industry with the release...
Dec 28, 20235 min read
US FDA’s final guidance on Digital Health Technologies for Clinical Investigations
The landscape of clinical investigations is evolving rapidly with the integration of Digital Health Technologies (DHTs). The US FDA has...
Oct 29, 20235 min read
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 in the...
Oct 23, 20236 min read
The Q-Submission Meetings for Medical Devices with US FDA
The US Food and Drug Administration (US FDA) Q-Submission Program serves as a vital channel for medical device manufacturers to engage...
Oct 20, 20234 min read
US FDA RFD and 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 the development...
Oct 4, 20236 min read
The US Agent: Your Essential Partner for FDA Regulatory Success
The United States Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and effectiveness of medical devices,...
Aug 9, 20235 min read
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 9.48 billion in 2022 and...
Jun 20, 20232 min read
Expanded Access by USA FDA for Investigational Drugs
In the United States, the approval process for unregistered medicinal products under Early Access Program (EAP) is known as Expanded Access
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