Regulatory

After a biosimilar or interchangeable product gets regulatory approval by the USFDA, manufacturers often need to adjust their manufacturing processes. These changes after approval are essential for keeping product consistency, enhancing processes, or tackling operational issues. However, because biologics are complex, even small modifications can significantly affect the product’s safety, efficacy, and quality. As a

In the past four decades, the number of drugs being approved by the FDA has increased significantly. Interestingly, while the number of products has only increased, the time taken by the FDA to review and eventually market them has steadily decreased. A recent article by Seoane-Vazquez and team shows that while the median time to

In the pursuit of global harmonization in pharmaceutical regulation, Japan which is renowned for its meticulous standards and innovative spirit, has taken a significant step by implementing the Electronic Common Technical Document (eCTD) v4.0. This move aligns Japan with international standards set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human

The accelerated approval pathway is established to expedite the availability of drugs for serious or life-threatening conditions. It allows the FDA to approve treatments based on surrogate or intermediate endpoints before confirmatory studies are completed. This pathway has been instrumental in advancing treatments for rare diseases and unmet medical needs, relying on a balance between

In the early days of drug development, pioneers had two routes: the traditional New Drug Application (NDA) or its generic type, the Abbreviated New Drug Application (ANDA). The NDA involved extensive original comprehensive research and clinical trials, while the ANDA was a well-travelled path for a generic drug, relied on safety and efficacy data of