FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Updates Medication Guide Database

Aug. 10, 2018

The FDA launched an updated Medication Guide database to replace its existing page, offering streamlined data entry for speedier updates and better access on mobile devices.

The guides reflect FDA-approved labeling for patients and address issues specific to individual biologics or prescription drugs. The updated database includes information on APIs.

Sponsors are required to submit the guides in cases where certain information is necessary to prevent adverse effects and where adherence to directions is essential to a drug’s effectiveness.

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