Regulatory Affairs

19
Jun
Curiouser and Curiouser! Late-Cycle Amendments under GDUFA III Part 2 - Lachman Blog 2

Curiouser and Curiouser! Late-Cycle Amendments under GDUFA III Part 2

The last blog that we drafted on this topic, The Curious Case of the Late Cycle Amendment under GDUFA III, was posted last summer (here). As a quick refresher on what we covered, the GDUFA III Commitment Letter (here) included several new enhancements to the Generic Drug User Fee Program, one of which was the inclusion of […]

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19
Jun
A Peek at the June 2024 Mid-Month ANDA Approval Actions - Lachman Blog

A Peek at the June 2024 Mid-Month ANDA Approval Actions

After two stellar months, the OGD approvals (at least through mid-June) appear to have slowed down a bit, with 31 full-approval actions and six tentative-approval (TA) actions reported through June 16th (here). While there is still time for the approval pace to pick up during the latter part of June, with 37 total approval actions […]

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18
Jun
Suitability Petition Metrics - Lachman Blog

Suitability Petition Metrics

Any frequent reader of the Lachman blog is well acquainted with the blog’s affinity for commenting on approval metrics from the Office of Generic Drugs (OGD). Today’s blog will also address metrics, but, in this case, the metrics are related to suitability petitions and are completely unofficial as the OGD has yet to publish or […]

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18
Jun
FDA Finalizes New Final Guidance on Facility Readiness and Goal Dates - Lachman Blog

FDA Finalizes New Final Guidance on Facility Readiness and Goal Dates

The FDA received no comments on the draft guidance titled Facility Readiness: Goal Date Decisions Under GDUFA, and, as such, has finalized the guidance with only minor editorial changes. The advance prepublication of the Federal Register Notice (here) notes, “[U]nder the commitment letter related to the GDUFA authorization for fiscal years 2018 through 2022 (under […]

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11
Jun
Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality - Lachman Blog

Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality

Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]

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06
Jun
Compounded Drugs and the Potential for Sulfite Allergies - Lachman Blog

Why Didn’t I Think of This? Compounded Drugs and the Potential for Sulfite Allergies

On June 6, 2024, the FDA warned patients and healthcare professionals of the potential danger of sulfites in compounded medications. Remember that prescription products that contain sulfites are required by law to contain a sulfite warning due to the potential for serious adverse events in patients who have sulfite allergies. The warning (here) notes that the […]

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03
Jun
Just a Quick Note – OMUFA Facility Fees Due TODAY – Monday, June 3, 2024 - Lachman Blog

Just a Quick Note – OMUFA Facility Fees Due TODAY – Monday, June 3, 2024

This morning, the FDA published a reminder (here) that over-the-counter (OTC) monograph user fees (OMUFA) for facilities must be paid today, noting that it “is in reference to the March 29, 2024, Food and Drug Administration Federal Register notice (FRN) titled ‘Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024.’ The fiscal year […]

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30
May

The Future of Visual Inspection 

It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]

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