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Reminder that CARES volume reports for 2024 are due no later than 31 March 2025. If you need assistance with the process, EAS is here to help.

The FDA has updated the OTC MONOGRAPHS @ FDA website’s OTC Monograph Resources section.  This includes a digital Catalogue of Pre-OMUFA Documents dataset in a downloadable excel spread sheet.  This catalogue includes a list of documents that were only accessible as paper documents prior to the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The resource page also includes a link to the FDA’s Historical Status of OTC Rulemakings webpage and an FAQ section.

All Guidance Documents can be searched on the FDA’s website.

 

Posted in Drug and Device Corner, Drugs, Medical Devices.