iwewlkws 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
It is not uncommon for sponsors to use research labs in academic settings for specialized clinical tests not available commercially. However, the convenience of using such labs comes with its own challenges particularly when the sponsor does not follow common sense measures to ensure the quality and reliability of the tests conducted at these labs, … Read more
Experimental data from research in non-human primates, which is almost always rhesus monkeys, is considered critical for establishing the safety and efficacy profile of many new drugs in market approval applications to the FDA. So, the ethical and legal acquisition of animals for this research is an important consideration. This week, an expose in Bloomberg … Read more
There are a few important considerations for the Informed Consent Document (ICD), also called the Informed Consent Form (ICF), used by sponsors to consent clinical trial participants which could improve the quality of the consent process and possibly increase trial participation. The design of the ICD varies extensively due to the experience of the sponsors … Read more
There have been a few smartwatch apps and smart rings claiming to measure blood glucose levels without piercing the skin or sampling blood. These devices and apps are not regulated and hence can be sold directly to consumers without any independent validation and are popular because of their seeming ease of use. However, these devices … Read more
The format of FDA meetings has changed dramatically since the pandemic from mostly in-person to almost all virtual meetings. Should the in-person meetings come back to the pre-pandemic levels? There are several opinions to that debate. This week, FDA’s senior officials opined at a conference on the topic, and it seems there are divergent opinions. … Read more
ChatGPT can revolutionize the medical note taking process for clinical practices but it can exert unpredictable effects on clinical decision making by introducing nuances. A perspective in a recent publication in the Journal of American Medical Association (JAMA) provides a few pointers to what developers and practitioners must plan for when using ChatGPT or similar … Read more
