While many people are aware that on March 27, 2020, the Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act, not all know about a surprised addition to this Act: Over-the-Counter Monograph Safety, Innovation, and Reform Act. The OTC monograph reform provisions significantly modify FDA’s regulation of OTC monograph drug products, including moving
Prior to this Coronavirus mess, we had several of our foreign clients scheduled for inspections by the FDA. then everything came to a halt and the FDA investigators were basically on a home lock down. The FDA had always had the authority to request company information under the section 704(a)(4) of the Federal Food, Drug
Industry update MDR postponement – handle with care! The proposal for a one -year delay of Regulation (EU) 2017/745 on medical devices (MDR) that was proposed the European Commission has been confirmed by the European Parliament. The last step in the process will be a sign-off by the European Council. This is rather a formality
In our experience, the most common mistake medical device manufacturers make is to conduct clinical trials they design themselves without a reimbursement consultant’s input. A study which results in adequate scientific evidence to prove that your medical device is effective in improving the clinical outcomes of patients is crucial for you to obtain coverage from
NO SURPRISE – But a long time coming. Josh Hawley (R., Mo.) announces a new bill “The Medical Supply Chain Security Act” which will help reduce the reliance on Chinese medical supply chain. This is due to the current coronavirus outbreak and addresses potential shortages. The new bill amends “shortage of a drug” to add,
Update on Enforcement Policy for Face Masks & Respirators During the COVID-19 Public Health Emergency This week, the FDA released a guidance outlining their enforcement policy regarding face masks and respirators during the Coronavirus (COVID-19) public health emergency. This includes general use face masks for the general public and particulate filtering face-piece respirators (i.e. N95
The COVID-19 pandemic interrupted many aspects of our lives as we know it. One of the critical concerns on the FDA list is how to handle the ongoing clinical studies during the current pandemic. With that in mind, FDA issued a new document titled “FDA Guidance on Conduct of Clinical Trials of Medical Products During
We have reported previously that US FDA stopped sending their personnel to inspect foreign manufacturers in China due to widespread outbreak of COVID-19. As reported today, the FDA is now postponing most foreign inspections through April, effective immediately. However, inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For US-based
The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19). These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA is particularly concerned that products that claim to cure, treat or prevent
This week the FDA has issued a final rule banning Electrical Stimulation Devices (ESD’s) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of injury or illness that cannot be corrected or eliminated through new or updated device labeling. These devices have been associated with an extensive list of serious
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