FDA Announces New and Updated Drug and Medical Device User Fees

FDA Announces New and Updated Drug and Medical Device User Fees

FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with the newly established Over-the-Counter Monograph User Fee Program (OMUFA), enacted as part of the...

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USDA to Strengthen Organic Regulations

USDA to Strengthen Organic Regulations

Recently U. S. Department of Agriculture (USDA)’s Agricultural Marketing Service (AMS) released a proposal to modify organic regulations. The proposed rule is intended to increase oversight of industry and institute more procedures for certifiers and...

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DOJ Charges Manufacturer for Exporting Misbranded Masks

DOJ Charges Manufacturer for Exporting Misbranded Masks

On June 5, 2020, the U.S. Department of Justice (DOJ) charged a Chinese manufacturer with exporting misbranded face masks, purported to be N95 respirators. The criminal complaint against King Year Printing and Packaging Co., Ltd. includes numerous allegations that it...

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New EUA Requirements for Serology Tests

New EUA Requirements for Serology Tests

On May 5th, the FDA added a very significant new requirement for commercial manufacturers of COVID-19 serology tests that are currently on FDA’s so-called “section IV.D list”: Submit a complete Emergency Use Authorization (EUA) Request to FDA before Monday, May 18,...

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Warning about Face Mask Imports

Warning about Face Mask Imports

Update 6/10/2020 On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by...

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FDA Expands EUA to Include more Imported Disposable Face Masks

FDA Expands EUA to Include more Imported Disposable Face Masks

Update 06/10/2020 On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by...

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