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16
May

FDA Issues Next Batch of New and Revised PSGs 

Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here).  PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product.  These latest PSG additions […]

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16
May

SBIA’s FDA PSG Webinar – OGD Discusses the Dissolution Database 

At the Center for Drug Evaluation & Research (CDER) Small Business Industry Assistance (SBIA) meeting held on April 25th, titled “Facilitating Generic Product Availability Through Product-Specific Guidances (PSGs) for 2024,” the FDA presented some updates regarding the FDA Dissolution Database.  Dr. Leah Falade, Senior Pharmacologist in the Office of Pharmaceutical Quality, CDER, was the presenter in Session 6.  […]

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10
May

Are You Getting the Most Out of the PSG Program Under GDUFA III? 

The FDA recently hosted a webinar focused on the facilitation of generic drug product development through Product Specific Guidances, also known as PSGs.  The CDER Small Business & Industry Assistance (SBIA) held a webinar titled Facilitating Generic Product Availability Through Product-Specific Guidances (PSGS) for 2024 on April 25th.  The slides and recordings will soon be posted […]

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07
May
Should FDA Have More Say Over Patent Listings in the Orange Book - Lachman Blog

Should FDA Have More Say Over Patent Listings in the Orange Book?

This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology (here), suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book (OB). She addresses the Hatch-Waxman Act’s patent listing provisions and discusses other views held on the […]

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03
May

We’ll see you at the 2024 FDLI Annual Conference!

Join us at this year’s conference for a great exchange of ideas, and the celebration of FDLI’s 75th Anniversary! Lachman Consultants is excited to be part of the upcoming 2024 Food and Drug Law Institute (FDLI) Annual Conference, scheduled for May 15-16 in Washington, DC. The conference serves as an invaluable platform for professionals across […]

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03
May
April 2024 Unofficial ANDA Approval Actions – Back on Track - Lachman Blog

April 2024 Unofficial ANDA Approval Actions – Back on Track?

Well, it must be true that April showers bring May flowers. A shower of approvals in April is something we haven’t seen in a while. The OGD unofficially issued sixty-eight full-approval actions and eleven tentative-approval actions for a total of seventy-nine for the month. We still must wait for the official numbers to be posted, […]

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01
May
Are You Still Using Your Grandma’s Container-Closure Integrity Approach - Lachman Blog

Are You Still Using Your Grandma’s Container-Closure Integrity Approach?

Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, […]

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30
Apr
More on the Final Rule on ANDAs and 505(b)(2) Applications Image

Final Rule on IVDs Issued, Along with Two Guidance Documents 

FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here).  This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023.  FDA explains that since  “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]

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