Reporting requirements


CARES Act – What’s New for 2023?

It’s that time of year.  Taxes?  Well, yes, but that’s not what I’m talking about.  Instead, I’m referencing the equivalent for those of us in the pharmaceutical industry—CARES Act reporting.  In the last couple of weeks, a flurry of emails arrived for many of us from the FDA, reminding us that: “Under section 510(j)(3) of the […]

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A Look at the Reporting Requirements Described in the GDUFA III Commitment Letter

The FDA is changing its reporting requirements for GDUFA III.  It appears from the changes that some information may be more difficult to gather and will be removed from the monthly Generic Drugs Program Activities Report we have all come to love and will be moved to either quarterly or annual reports. The monthly report […]

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