FDA Databases: Noncompliance Letters, Medication Guides – Drug and Device Digest

FDA Brief: Week of Feb 15, 2016



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Non-Compliance Letters Listing

WHAT: Identifies drug and biologic products for which the sponsor has received a pediatric research Equity Act (PREA) Non-Compliance letter

WHY: Sponsors required to submit pediatric assessments required by PREA as part of drug approval

HOW:  Provides links to the PREA Non-Compliance letter and sponsor response. When the sponsor fulfills, FDA will add the date to the last column of the table




Medication Guide Database

WHAT: Paper handouts provided with certain prescription medicines. Contain information to avoid serious adverse events

WHY : FDA requires  Medication Guides be issued when  Agency determines that certain information is necessary to prevent serious adverse effects

HOW:  Inform Patient decision-making  by information about known serious side effect, or patient adherence to directions for the use



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