FDA Update – COVID-19 – FDA Continues to Combat Fraudulent COVID-19 Medical Products No Surprise here – the FDA needs to make use of their Investigators who are locked in their homes. They are scanning the internet for Fraudulent Advertising concerning the COVID -19. At the end of the first week in May, FDA provided
Policy for Coronavirus Disease-2019 Tests During Public Health Emergency In the first week of May, the FDA released a new guidance document: “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).” This new policy supersedes the guidance document issued during the second week of March. This new guidance document highlights policies for accelerating
ALCOHOL-BASED HAND SANITIZERS Due to COVID-19 pandemic, the FDA released an announcement on April 27, 2020 about the availability of alcohol-based hand sanitizer. The FDA wants to address safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims. Due to the increased
RE: Update on Enforcement Policy for Face Masks & Respirators During the COVID-19 Public Health Emergency During the first week of April, the FDA released a guidance document outlining the up-to-date policy regarding face masks and respirators during the Coronavirus (COVID-19) public health emergency. The reason for this guidance is to help expand the availability
April 26, 2020 – NEW REQUIREMENTS for the export of MASKS made in China – the Chinese Government now requires that all companies looking to export PPE device have a declaration by both the Foreign Exporting company and the importer (the USA company) certifying that are in agreement that quality standards. (see attachment 1) Attachment
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
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
mdi Consultants