Cybersecurity requirements for FDA-regulated devices are evolving rapidly to stay in step with technological developments. This week the FDA released a detailed guidance document addressing several security issues around medical devices connected to the internet currently in development. The directions in this guidance document could append the ongoing development plans for internet-connected medical devices or … Read more
Meeting the FDA is unquestionably the most important resource available to sponsors/developers of new drugs and biologics. Over the last 30 years, these meetings have evolved into complex procedures. Their potential outcomes depend not on just what you ask but how you ask and when you ask the FDA about a particular issue related to … Read more
There have been numerous controversial decisions by the FDA in recent years where it approved new drugs despite its Advisory Committees (AdCom) recommending against it. But the FDA, being an equal opportunity disagreer, at times also rejects drugs that were recommended by its AdCom for approval as was shown this week when it rejected an … Read more
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
