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13
Jun
Information on DSCSA Exemptions Until November 2026 and Other Possible Waiver Exemptions for Small Dispensers - Lachman Consultants

Information on DSCSA Exemptions Until November 2026 and Other Possible Waiver Exemptions for Small Dispensers

Now, don’t get too excited as this likely will not apply to you (see below for more detail for non-small dispensers)! The FDA expects all entities to be fully compliant with the Drug Supply Chain Security Act (DSCSA) by November 27, 2024; however, there are certain exemptions for what the Agency describes as “small dispensers” that […]

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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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29
May
Biosimilar Switching – RWD Evidence Supports Center for Biosimilars Contention - Lachman Blog2

Biosimilar Switching – RWD Evidence Supports Center for Biosimilars Contention

A May 28, 2024 review article by Skylar Jeremias titled, “New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching” (here), supports the fact that switching between biologics and biosimilars or from one biosimilar to another does not present a problem. The article states “[S]ince the July 2022 publication of the first systematic review of biosimilar-to-biosimilar switching, the European […]

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28
May
Making Sense Out Of The IRA - Lachman Blog

Making Sense Out Of The IRA? – Good Luck To You!

As one would expect from a consulting service that focuses primarily on the Regulatory and Compliance sectors, the Lachman Blog has not historically focused on issues that are primarily economic in nature, unless the discussion is related to drug shortages. When searching our blog archive, I only found a single reference to the issue that […]

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