iwewlkws 510k constitutes both the most common kind of device market approval applications and the most controversial ones due to predicate creep, need or not of clinical trials, and the amount of supporting information needed for clearance by the FDA. These very critical strategic considerations could vastly affect the time needed for the creation of a … Read more
The US government is investing heavily in finding new COVID-19 vaccines both to treat acute infections and to treat long-term side effects of Covid, called Long Covid. In that regard, the US Department of Health and Human Services (HHS) announced an award of $1.4 billion for its latest efforts of which $1 billion will be … Read more
Real World Data (RWD) collected from medical records and the Real World Evidence (RWE) generated from it can be used to seek market approval for new uses of FDA-approved products by the FDA. However, there are specific FDA requirements for the quality and integrity of the RWD before its acceptance by the FDA. A new … Read more
Patient advocacy organizations (PAOs) have a vital role in raising awareness about diseases and representing patient interests with the industry and FDA. In the last few years, PAOs played a critical role in raising patients’ opinions about controversial new drugs with the FDA, in turn leading to the approval of those drugs by the FDA. … Read more
Unlike pharmaceuticals, supplement ingredients don’t undergo FDA preapproval for effectiveness or safety prior to market introduction. This regulatory gap has paved the way for manufacturers to overlook basic manufacturing standards, resulting in compromised product quality. The identity, purity, and composition of dietary supplements are often neglected, which becomes a critical issue given the complex physiological … Read more
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
