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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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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20
May
AI developments blog 20May2024 - Lachman Consultants

Are AI Developments Outpacing Your QMS Maturity?

Forget the cadence of the traditional three-to-five-year business plan when it comes to Artificial Intelligence (AI). The pace of change in this environment has indicators that need to be followed on a quarter-by-quarter basis. In Q1, we wrote about the fast evolving environment both from the legal perspective and the regulatory aspect in blogs that […]

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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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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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26
Apr
3d illustration of a battleship firing with heavy caliber guns

Q1/Q2 Formulation in Labeling Gets Promoted in New FDA Guidance Addressing Components and Composition in NDA and ANDA Applications

Today, the FDA has published a new draft guidance titled Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDA (here) that describes the FDA’s current thinking on consistency of composition statements in NDAs and ANDAs.  It provides a clear and unambiguous requirement to list both the qualitative […]

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