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Fees Regulatory Requirements Food and Drug Administration (FDA)

Gardner Law

The Value of MDUFA

Gardner Law on

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

Environmental General Counsel PC

CalRecycle Releases New EPR Packaging Regulations: Imminent Compliance, New Exclusions, and Deferred Eco-Modulation Implementation

A lot is going on in the extended producer responsibility (“EPR”) packaging world this month.  Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws.  And this week, just a...more

Hogan Lovells

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

Hogan Lovells on

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

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