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Category Archives: FDA Updates

05 May

FDA Update: COVID-19 TEST

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

01 May

FDA Update: COVID-19

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

28 Apr

FDA Update – COVID-19

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

26 Apr

SFDA (Chinese Government) update

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

23 Apr

FDA update: NEW U.S. LEGISLATION TO IMPACT THE OVER-THE-COUNTER (OTC) DRUGS INDUSTRY

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

17 Apr

FDA Update: New Bill “The Medical Supply Chain Security Act”

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,

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