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Additional FDA Validations Begin Sept. 4

The Food and Drug Administration is again reminding the trade that starting Sept. 4 the agency will deploy three new validations. Failure to provide the correct information will result in a reject of the entry. The changes include: A validation to check the syntax of...
FDA Resources for Approvals

FDA Resources for Approvals

As we look forward to a ramping up of distribution efforts for the eventual COVID-19 vaccine, there is a very clear need for capacity and FDA-approved cold chain infrastructure. In order to participate in the pharmaceutical supply chain, it is important to obtain...
Filing Entries of Hand Sanitizers for FDA

Filing Entries of Hand Sanitizers for FDA

CSMS #42590577 The U.S. Food and Drug Administration (FDA) is providing this update to clarify expectations regarding filing entries of hand sanitizers. FDA has recently become aware that some entries of hand sanitizers have been disclaimed to the FDA, and the full...
FDA FAQs on Shortages of Surgical Masks and Gowns

FDA FAQs on Shortages of Surgical Masks and Gowns

The following was just published to the FDA website in order to help importers and distributors better understand the regulatory environment around critical medical supplies during the COVID-19 crisis. Q1. Is there a shortage of gowns? Surgical masks? The FDA is...

FDA End-Dated and New CDER Product Codes

CSMS #42090240: Food and Drug Administration (FDA) End-Dated and New Center for Drug Evaluation and Research (CDER) Product Codes The Food and Drug Administration (FDA) will be end-dating two Center for Drug Evaluation and Research (CDER) product codes listed...
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