The Lachman Blog

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01
Nov
Female biologist testing the oxygen levels in the river

Water Conductivity Testing: More Than a Simple Test

Water is a critical component used in the manufacture of pharmaceutical products, and it must meet specific quality standards in order to demonstrate that the water intended to be used for manufacture is suitable for its intended purposes.  USP <1231> on Water for Pharmaceutical Purposes provides an overview of the different water types used in manufacturing, […]

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01
Nov
Blog Brief on Several FDA Actions and Topics of Interest - Lachman Blog Image 2

Brief on Several FDA Actions and Topics of Interest

Baxter Recovery and FDA Actions The FDA announced additional actions “to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina.”  The FDA performed assessments to enable import of IV solutions and PD solutions from seven different Baxter […]

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31
Oct
young professional who is writing down math formulas

Are Your Methods Fit for Purpose?

When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]

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30
Oct
Reduce risk level or decrease stress anxiety meter, lower danger indicator or scale, reduce from red alert meter to be green chart concept, businesswoman pull meter to reduce risk or stress level.

First Tranche of PSGs Removing BE Fed Study Requirements to Publish Tomorrow

A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed.  In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence […]

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25
Oct
The FDA Commissioner Takes a Seat with AAM on the Final Day of GRxBiosims Conference - Lachman Blog

The FDA Commissioner Takes a Seat with AAM on the Final Day of GRx+Biosims Conference

On the last day of GRx+Biosims, David Gaugh, Executive Vice President of AAM, had a fireside chat with Robert Califf M.D., commissioner of the Food and Drug Administration. The Commissioner’s comments echoed many of the themes discussed by other industry and FDA participants during the meeting, especially regarding the worry about sustainability of the generic […]

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23
Oct
Day Three of the AAM GRx-Biosims Conference - Lachman Blog

Day Three of the AAM GRx-Biosims Conference

It is the last day of the conference, and we have some highlights for you. In a keynote address, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research provided a State of the Biosimilars and Generics Program. By the numbers she indicated that in Fiscal Year (FY) 2024 OGD: Has […]

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22
Oct
The sun's up and so is my mood

AAM Brief Look Back at Day One and Some Thoughts on Day Two

My fingers were tired last night so I did not get to capture a highlight of the presentation made by Dr. Iilun Murphy, Director, Office of Generic Drugs, which is usually one of the biggest draws of this annual conference.  So, let’s take a step back and provide you with some tidbits from her presentation. […]

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18
Oct
Focused businessman analyzing marketing reports on a desktop monitor and reviewing paper graphs, financial stats, and startup project infographics.

OGD Official Statistical Report for August 2024, Plus Mid-Month October 2024 Approval Actions

The official August 2024 statistical report was published by the FDA on October 17, 2024 (here).  Let’s run through the numbers and then we’ll take a look at the mid-month approvals for October 2024 (the first month of the new Fiscal Year 2025). The official August approvals were a couple below what we had predicted when […]

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