The analytical method validation process varies depending on the regulatory bodies governing drug development and the product’s intended use. The regulations do not provide detailed descriptions of AMV, so pharmaceutical companies and contract ...
marketing and premarket submissions to global regulatory bodies. 01 Cancer and Carcinogenicity The World Health Organization (WHO) defines cancer as a group of diseases caused by the rapid proliferation “of abnormal cells that grow beyond their usual bound...
Complaints addressed by self-regulatory bodies were not included due to the poor availability of data. Sixty complaints, 374 complaints, and 223 complaints from the United Kingdom, Canada, and Australia, respectively, were analyzed. In the United Kingdom, the most frequent type of violation was ...
(cilta-cel) has demonstrated exceptional efficacy in studies conducted worldwide, which has resulted in regulatory approvals in >40 countries. Herein, we examine the regulatory pathways that led to its approval in different regions, focus on challenges in clinical development and regulatory submission...
of Technical Requirements for Pharmaceuticals for Human Use (ICH).9–20 Finally, specific considerations related to model choice and study design are presented, followed by a discussion of how carcinogenicity data should be presented in marketing and premarket submissions to global regulatory bodies. ...
Rare disease (RD) management and orphan drug development in India face various hurdles regarding the implementation and adoption of comprehensive policies, lack of dedicated regulatory frameworks, and absence of epidemiological data. Current rare disease
Drug product data is available on the Web in a distributed fashion. The reasons lie within the regulatory domains, which exist on a national level. As a consequence, the drug data available on the Web are independently curated by national institutions fr
Efforts were conducted by regulatory agencies and the U.S. government through Medicare to enhance the financial appeal of antibacterial medications [99,106,107]. This was conducted to enhance the discovery of additional antibacterial medications [97,108], including drugs that are effective against ...
schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. However, some countries did not actively promote their patient reporting schemes. Our findings indicate that countries with minimal experience in pharmacovigilance systems that include direct patient ...
On the regulatory outlook, the regulatory bodies have set stringent regulations for the approval of combination products. They have now focused on analyzing the drug formulations and not only the device efficiency. Due to frequent changes in the regulations, manufacturers find it challenging in launchi...