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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Systemic Lupus Erythematosus --Developing Medical Products for Treatment  Food and Drug Administration (FDA) Final
Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation  Food and Drug Administration (FDA) Final
Tabulated Values of Accessible Emission Limits for Laser Products  Food and Drug Administration (FDA) Final
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency   Food and Drug Administration (FDA) Final
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry  Food and Drug Administration (FDA) Final
Testicular Toxicity: Evaluation During Drug Development  Food and Drug Administration (FDA) Final
The Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification   Food and Drug Administration (FDA) Final
The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12  Food and Drug Administration (FDA) Final
Third of a series of letters regarding the implementation of the Act  Food and Drug Administration (FDA) Final
Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k))  Food and Drug Administration (FDA) Final
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