State and Federal Regulatory Changes for Early January 2024
As we begin our 2024 regulatory journey, state and federal regulations haven’t slowed down in the slightest. Even in the first week of January, there have been multiple changes from state boards and new guidance from the FDA to pay attention to. Here are just a few of the changes introduced at the start of 2024.
FDA Letter to Medical Device Manufacturers: Exporting Documents (01/02/2024)
On January 2, 2024, The FDA changed from issuing paper to electronic export documents for medical devices. All export documents issued by CDRH on or after January 2, 2024, will be delivered electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS). With the new electronic process, you will receive an email notification of approval with detailed instructions on how to access the document. One time access will be granted to print or download the document within 45 days of issuance. After 45 days, the document will no longer be available to print or download. IMPORTANT NOTE: Apostilles and authentications of certificates must be printed in color to be valid. The letter with more information can be found at: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry
FDA Guidance: Veterinary Fees (01/03/2024)
The Food and Drug Administration is announcing the availability of a final guidance for industry, “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species, along with Drug User Fees for MUMs drugs and Animal Drug Applications. Comments for Docket DFA-1997-D-0444 are accepted till 1/11/2024 and can be found at: https://www.regulations.gov/government/FDA-1997-D-0444-0037.
Minnesota Wholesale Drug Distributor Tax 2023 Filing Opens 1/22/2024
The 2023 Wholesale Drug Distributor Tax can be filed electronically starting January 22, 2024. The annual return is due by March 15, 2024. If you are required to make quarterly estimated tax payments, you must make your fourth quarter payment, due January 16, 2024, for 2023 before filing your 2023 return. The tax form can be completed on paper: https://www.revenue.state.mn.us/sites/default/files/2023-12/2023-minnesotacare-wholesale-drug-distributor-tax-instructions.pdf or completed online: https://www.mndor.state.mn.us/tp/eservices/_/
Virginia Places Chemicals in Schedule 1 Effective 1/31/2024
Effective 1/31/2024, Virginia has placed synthetic opioids and cannabimimetic agents into Schedule I of the states controlled substance list. The placement of drugs listed in this subsection shall remain in effect until July 31, 2025, unless enacted into law in the Drug Control Act.
Staying Up to Date with 2024 Regulatory Changes:
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