iwewlkws Medical devices with software that connects to the internet and creates a potentially unaddressed cybersecurity vulnerability will be rejected by the FDA, starting 29 March 2023. The policy, which has been tacitly in effect since 2014 via Guidance Documents, is now being formalized into a Refuse-to-File (RTF) criteria. So, what’s new here? Many medical devices … Read more
This week FDA updated its Medical Foods guidance to clarify and expand on its previous guidance from 2016. The main update is regarding the requirement for allergen warning on medical food labels but there are several other pointers in the guidance about medical foods to answer common questions from consumers and industry alike. Medical foods … Read more
FDA allows animal drug approvals based entirely on published literature provided the selected publications adequately justify the specific claims in the market approval application and meets well-established scientific quality standards. Published literature lacks several quality standards essential for regulatory acceptance as sole evidence. FDA’s latest guidance on the topic lists those challenges and suggests ways … Read more
Electronic Records are an integral part of clinical practice and hence also of clinical trial source documents. In its 2017 Guidance on using electronic records in clinical trials FDA provided several suggestions on best practices for sponsors and clinical research organizations. This week FDA released an updated Guidance that expands on the original guidance to … Read more
Over the last 3 decades, expanded access or emergency use treatments have become quite common and clinical experience from expanded use of investigational products has even been used to provide additional safety data to the FDA and enrich the real-world evidence (RWE), particularly for rare diseases. But use of expanded access protocols also raises concerns … Read more
Use of Artificial Intelligence (AI) is being explored for several aspects of manufacturing FDA regulated products which raises new concerns that must be considered according to a Discussion Paper released by FDA this week. FDA would like the industry to comment on these concerns so suitable regulatory policies can be created for such systems. There … Read more
Artificial Intelligence systems such as ChatGPT can be used for creating summaries, discussions, and generating ideas. Can that be expanded to designing new drugs and finding new uses or previously approved drugs? ChatGPT uses publicly available information to summarize and pseudo-analyze specific questions posed to it providing seemingly intellectual assessments. The software can theoretically be … Read more
A heartrending article by a former assistant secretary of public affairs and deputy chief of staff at the Department of Health and Human Services, highlights the disconnect between FDA’s requirements for critical drug approval and patients’ need. This is not the only case of its kind where patients and physicians complain of the opacity of … Read more
A couple of weeks back Pfizer announced that it is dropping about 3500 patients recruited to its Phase 3 clinical trial for a vaccine for Lyme disease due to GCP compliance issues related to its “clinical trial site operator”, Care Access. This is not normal; rather this is likely the only incidence of its kind … Read more
Under the drug pricing competition provisions of the US regulations, for the last few years FDA has implemented several programs to encourage multiple manufacturers for each generic drug product. However, these efforts are limited to the finished product manufacturers only and not to the ingredient suppliers. Lack of competition for API manufacturing creates a vulnerability … Read more
