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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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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22
May
Skinny Is As Skinny Does – At Least When it Comes to Labeling Carve-Outs- Lachman Blog

Skinny Is As Skinny Does – At Least When it Comes to Labeling Carve-Outs

The Association of Accessible Medicines (AAM) and the BioSimilars Council (a Division of AAM) released a statement of support (here) for a legislative fix to provide a safe harbor for generic / biosimilar label carve-outs. The issue is the potential threat of litigation for inducement to infringe, a problem that could bankrupt a generic or […]

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17
May
Spring desert wildflowers in Anza Borrego Desert State Park, CA

Mid-May 2024 Peek at ANDA Approval Actions

April’s unofficial totals for approvals actions were discussed in a previous blog post here, and we mentioned that April showers might bring May flowers.  Well, the bloom of approvals so far in May might rival the bloom of flowers that we’re seeing in the California deserts this year! The approval actions posted through May 16th […]

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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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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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