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Category Archives: FDA Updates

27 May

FDA Update: Supplements for Approved Premarket Approval (PMA)

May 27, 2020 - 9:33 pm
FDA Updates

Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency The FDA released a new guidance document on May 21, 2020 addressing manufacturing limitations or supply chain issues due to disruptions being caused by the COVID-19 public health emergency. This policy applies to limited

23 May

FDA Update – Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection

May 23, 2020 - 2:25 pm
FDA Updates

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection As we move further along with this Corona Virus Pandemic situation, with the “world” trying to get their PPE, most importantly, face masks, the quality of the masks is under suspect. To assure that the masks are providing the protection that they claim

14 May

FDA Update – FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

May 14, 2020 - 6:51 pm
FDA Updates

On May 11, 2020 the FDA released a press announcement to address new actions to help accelerate the development of prevention and treatment options for COVID-19. The FDA has provided new guidance with recommendations for innovators and researchers. These guidance documents aim to make the process of submitting applications in initiate studies for new drugs

05 May

FDA Update: COVID-19 TEST

May 5, 2020 - 8:20 pm
FDA Updates

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

May 1, 2020 - 4:42 am
FDA Updates

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

April 28, 2020 - 3:11 pm
FDA Updates

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 - 7:04 pm
FDA Updates

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

April 23, 2020 - 12:51 am
FDA Updates

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

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