FDA proposes new rule for conversion to electronic drug info list
An Electronic Drug Registration and Listing System (EDRLS) has been proposed by the FDA that would include a complete list of drug products marketed in the U.S. A change from the current paper system, the new electronic list would be available to healthcare providers, government agencies, and healthcare payers and would include specifics such as dosage forms, ingredients, strengths, labeling, and manufacturing information.
FDA proposes switching to e-drug info list
An Electronic Drug Registration and Listing System (EDRLS) has been proposed by the FDA that would include a complete list of drug products marketed in the U.S. A change from the current paper system, the new electronic list would be available to healthcare providers, government agencies, and healthcare payers and would include specifics such as dosage forms, ingredients, strengths, labeling, and manufacturing information. Drug manufacturers would be responsible for submitting all drug information electronically to the new system. Proposed revisions would also reorganize and clarify current regulations and give the agency more control over the issuance of the National Drug Codes (NDCs) currently used to identify drug products.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
