Labeling

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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19
Dec
Generic Drug Cluster Has a Lot of Muster - Lachman Blog 2

Generic Drug Cluster Has a Lot of Muster!

The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most […]

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26
Nov
Warning message

FDA Updates Warning for All NSAIDs; Other Drugs to Come?

For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium).  In today’s CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was […]

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12
Aug
Section viii label carve-out - Lachman Blog

Generic Carve Outs and Inducement to Infringe Still Under Attack

We have written extensively about the attack on the section viii label carve-out that is permitted under the Hatch-Waxman Act (H-W); this carve-out allows certain changes to a generic drug’s labeling to avoid patent infringement or certain exclusivity protection (here, here, here, here, and here). This so-called section viii label carve-out was part of the delicate balance […]

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11
Jul
Guidance Gives Firms More Tools to Deal with Misinformation - Lachman Blog

Revised Q&A Guidance Gives Firms More Tools to Deal with Misinformation – Or Does It?

The FDA has just revised a guidance titled, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (here) which says: “This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and […]

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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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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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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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24
Apr
Revised QA Document on Promotional Activities for Biosimilars Released by FDA - Lachman Blog

Revised Q&A Document on Promotional Activities for Biosimilars Released by FDA

Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]

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