Prahsant Kumar Since the publication of the Critical Path Initiative over two decades ago which included smart trial designs, the FDA has introduced several innovative clinical trial designs to improve clinical trial conduct and expedite new drug developments. However, the adoption of those non-conventional designs has not yet become mainstream. Most clinical trials still follow traditional designs … Read more
New Dietary Ingredient (NDI) registration has been required for almost 30 years but the regulations for such registration are one of the hardest to enforce and frequently less understood. There are many perceptions, right or wrong, about the definition of an NDI, the contents of the application for registration, the FDA review process, and other … Read more
A genetic diagnostic test approved by the FDA has come under surprisingly strong criticism by researchers, physicians, and some public interest groups, so much so that they have petitioned the FDA to revoke its approval and that CMS should not cover it. But would the FDA rescind a test it approved based on non-FDA research … Read more
The last year and half have been fueled by the hype about the potential of Artificial Intelligence (AI) algorithms in replacing work done traditionally by humans, driven primarily by generative large language models (LLMs) such as ChatGPT. One area of lively debate is the ability of ChatGPT in analyzing health information to generate therapeutic decisions … Read more
Almost all discussions about food-borne illnesses focus on pathogens such as bacteria that may contaminate our food, but what about harmful chemicals? Chemical poisoning may take longer to show symptoms and may cause long-term health issues. However, the FDA has an active and robust program to prevent chemical poisoning from food consumed in the US. … Read more
A question as old as the modern drug industry is about the true benefit provided by new treatments. This is an important argument to justify the high cost of newly approved drugs compared to those available in the prior days and years. A study by researchers in Europe raises some interesting questions about the added … Read more
A survey by the General Accountability Office (GAO) reported many interesting facts about the state of clinical trial audits by the FDA inspectors. The purpose of the GAO survey was to identify deficiencies in the FDA audits for compliance with Good Clinical Practices (GCP), but in the process, it reports several surprising facts about the … Read more
A medical device company had to suspend its ongoing pivotal clinical trial and may lose the data collected in the trial so far because of major violations of Good Clinical Practices (GCP) found during an FDA audit. The Warning Letter issued to the company looks like a lesson in the basics of GCP compliance for … Read more
For the last few months, a new Law, called the Biosecure Act, has been gaining bipartisan support in the US Congress, which aims to ban business with Chinese biotech companies, the biggest of them WuXi companies. The law could have some serious consequences for the US customers of these companies. WuXi, which owns a few … Read more
FDA’s previous guidance on cybersecurity aspects of internet connected medical devices provides a detailed description of all the issues that manufacturers must address prior to filing their market approval applications with the FDA. This week the FDA released an update to a few sections of that guidance which would likely require updates to the market … Read more
