Biosimilars

12
Feb
An unhappy female student sitting on sofa, tearing paper when studying.

Regulatory Agendas for Various Agencies Disappeared from Federal Register

I guess this is the next step in the evaluation of what we can expect regarding proposals for future regulations.  Semiannual regulatory agendas, along with tentative timetables, are published twice a year (as the name implies) to outline regulations that each agency is planning on issuing for those regulations. Today, in the pre-publication of the […]

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07
Feb

More From Access 2025

There were a lot of great speakers at Access 2025, the Association for Accessible Medicines (AAM) annual meeting held from February 3rd to 5th. Here are a few of some of the most interesting topics that were discussed in fireside-chat formats. John Murphy III, President and CEO of AAM, posed questions to Alex Azar, former Secretary, […]

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06
Feb
FDA Everybody Is Guessing AAM Meeting Presenters Just Dont Know and Can Only Guess - Lachman Blog

FDA – Everybody Is Guessing! AAM Meeting Presenters Just Don’t Know and Can Only Guess!

“Disruption” was the common theme expressed by many panel members at this year’s Access 2025 meeting of the Association for Accessible Medicines in Amelia Island, Florida. In speaking to attendees, “I just don’t know what to expect” seemed to be the mantra of the day. The absence of FDA attendees also seemed to shake the […]

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14
Jan
The statue of justice Themis or Justitia isolated on white background

Is the “Skinny Label” On the Verge of Protection? Is this the last Chapter?

For those of you that have been following the saga of the attack on the skinny label, we may be getting close to a solution.  Remember that a skinny label is labeling that cuts out a particular use or information protected by patent or market exclusivity of the branded product.  This allows for a generic […]

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03
Jan
Testing substances

FDA Issues Draft Guidance to Assist in Compliance with 21 CFR 211.110

The Code of Federal Regulations at 211.110 is titled “Sampling and testing of in-process materials and drug products.”  This new draft guidance, issued by the FDA, is designed to assist drug product manufacturers in complying with this section of the regulations “to ensure batch uniformity and drug product integrity.  In addition, this guidance discusses related […]

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02
Dec

Are You Handling USP Reference Standards Appropriately? 

Over 30 years ago, one of my responsibilities was overseeing the company’s Reference Standard Program for marketed products.  In-house standards were maintained and provided to company locations throughout the world, which also included providing enough fully characterized/qualified drug substances or impurities to the USP to be considered as a potential future USP Reference Standard lot.  […]

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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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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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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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