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Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program | Epstein Becker & Green

Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program | Epstein Becker & Green
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Reviewing FDA VSMR Manufacturer Draft Guidance

Reviewing FDA VSMR Manufacturer Draft Guidance
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HHS Clarifies Difference Between Guidance and Rules


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WASHINGTON Healthcare providers, if you re concerned that any guidance from the Department of Health and Human Services (HHS) will be taken as gospel and enforced as regulation by Washington bureaucrats, HHS has two words for you: Don t worry.
On December 3, the agency finalized a Good Guidance Practices rule to help ensure that the public receives appropriate notice of new guidance documents and that HHS guidance documents do not impose obligations on regulated parties that are not already reflected in statutes or regulations, HHS said in a press release. This final rule . is part of a broader regulatory reform initiative within HHS. ....

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