iwewlkws Although traditional FDA approval for a new drug or biologic requires evidence from two or more clinical trials, it is possible for the FDA to approve new products based on evidence from a single clinical trial under certain conditions. A new FDA Guidance Document released this week describes these conditions. The law provides the FDA … Read more
The FDA approval and the CDC endorsement of the latest Covid booster vaccines were received with a generally lukewarm reception. The CDC, FDA, and other government agencies presented the Covid booster vaccines as akin to the annual flu vaccine having followed a process to identify the prevailing strains of SARS-CoV-2 virus similar to that used … Read more
Emergency use or compassionate use protocols rely heavily on IRB review of such use of an investigational product. Individual patients in life-threatening conditions can be treated without prior approval by the FDA or an IRB with the expectation that the physician using an investigational treatment on his/her patient would inform the FDA and a relevant … Read more
The US FDA offers a grant of up to $3.6 million in non-dilutive funding to researchers developing new treatments for orphan drugs with an unmet medical need through a competitive selection process. Although the orphan drug development grant is not discussed much in funding circles, it offers several benefits, additional to the funds, to the … Read more
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
