In the dynamic landscape of medical device innovation, the utilization of off-the-shelf (OTS) software has become a cornerstone for rapid development and enhanced functionality. However, it is hard for the developers of devices to include most details about the OTS software, the kind of which would be available to in-house software. To allow device developers … Read more
Despite extensive advocacy from the FDA, most pre-approval clinical trials lack diversity owing primarily to the unwillingness of certain segments of the population to participate in clinical trials. However, once a drug is approved by the FDA, its use is more diverse and representative of the demographic distribution of the general population. To take advantage … Read more
Under the Modernization of Cosmetics Regulations Acts of 2022 (MoCRA) all manufacturing facilities for cosmetics must register with FDA prior to distribution of their products in the US, however, so far, the specific procedures and requirements for this were not clarified by the FDA. For example, it is not clear who needs to register, the … Read more
In December of 2020, at the height of the Covid pandemic, the US Congress allocated $1.15 billion to NIH to study and find treatments for long-term side effects of Covid, the long Covid. Two and half years later, NIH recently informed the Congress that it has already spent almost a billion dollars of the allocated … Read more
Developing new drugs is an expensive and time-consuming venture. One would expect developers to conduct extensive due diligence before investing resources into developing a new drug. What if their due diligence is influenced by non-scientific factors such as herd instinct and fear of missing an opportunity? Can multiple independent developers make a common mistake? What … Read more
In the realm of clinical research ethics, the concept of dual-role consent has long been a subject of debate. Dual-role consent occurs when physician-investigators seek consent for research participation from patients whom they already treat. While it has raised concerns, this practice is quite common in clinical research, e.g., clinical oncology research, where studies are … Read more
This week, FDA announced the Voluntary Qualified Importer Program (VQIP) primarily designed for foreign food importers to expedite entry of their food products for human and animal consumption in the US. This program will be additional to the Foreign Supplier Verification Program (FSVP) that is required for the US-based importers of these products. The VQIP … Read more
The ICH E6 guidance document and FDA’s clinical trial guidance contain requirements for good clinical trials, but they do not address practical issues related to the conduct of clinical trials particularly in resource-limited and multi-national settings. All locations where trials are being conducted or planned to be conducted are not the same in terms of … Read more
Some manufacturing changes could affect the biological properties of human cellular and tissue-based products (HCTPs) to an extent that may require a new IND or a BLA supplement. Unlike drug products, HCTPs are manufactured with limited information on several key aspects of process and product characterization lending them to higher risk when changes are made. … Read more
Since its inception about 5 years ago, FDA’s Breakthrough Device Program has been involved in 67 new device approvals out of about 700 devices designated as breakthrough devices. A review of the devices designated as breakthrough and approved via this pathway indicates a few interesting trends for this program such the indications for which FDA’s … Read more
