06
Oct

Most User Fees for FY 2023 Appear on Federal Register Pre-Publication Page Today – But a Glitch with GDUFA Fees?

The schedules for the 2023 Prescription Drug User Fees (PDUFA) (here), Biosimilar User Fees (BSUFA) (here), and Medical Device User Fees (MDUFA) (here) have been posted and are scheduled for final publication on October 7, 2022.  However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the […]

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28
Sep

Know Your Systems!

It is evident from reviewing recent health agency citations that the FDA expects that firms have a deep understanding of any systems that generate data/records and that this is reflected in the firm’s lifecycle management of those systems. What does that mean, in a practical sense? Well, a component of this understanding must extend to […]

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28
Sep
Quality Agreements Image

Great Quality and Great Business Is Interdependence in Plain Sight?

If our supply chain was weak prior to the pandemic, this global event accelerated its failure.  These signals of weakness were laid bare during the pandemic  and identified in publications such as the 2019 report “Drug Shortages:  Root Causes and potential Solutions” (here).  Prior to the Covid PHE, focus on shortages was placed much more […]

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27
Sep

Here We Go Again! Virginia Rep. McEachin Does Not Get It!

Congressman A. Donald McEachin (VA-04) comments “Today, [I] introduced the Updated Drug Labeling for Patient Safety Act, legislation to direct the Food and Drug Administration (FDA) to allow generic drug manufacturers to update their product labeling with safety-related information.” (see here). He notes that “[T]he Updated Drug Labeling for Patient Safety Act is commonsense legislation […]

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22
Sep

September 2022 Peek at Approval Actions

Based on a strong start to the month, the OGD has issued forty approval actions but only two tentative approvals based on information posted through September 20th.  Sorry that this mid‑month review was a bit late; with about two‑thirds of the month gone, I don’t expect to see another month like those we’ve seen lately.  […]

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20
Sep

Remote Non-Inspection “Inspections”

Throughout the PDA-FDA Joint Regulatory Meeting that took place September 12-14, 2022 in Washington D.C., the subject of Remote Assessments (RA), also called Remote Interactive Evaluations (RIEs), was repeated over and over again in sessions.  This is not a new thing, as the Guidance for Industry (GFI), “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch […]

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15
Sep

Changes Forced Upon FDA and Industry Highlighted at PDA FDA Joint Regulatory Conference

At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to […]

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