Bioequivalence

04
Mar

Narrow Therapeutic Index Drugs, Generics, and Better Education  

FDA published a conversation piece on narrow therapeutic index drugs entitled, “Setting and Implementing Standards for Narrow Therapeutic Index Drugs” (here ) to better inform health care professionals (HCP), patients, and other consumers regarding the use of and how the FDA treats narrow therapeutic index (NTI) drugs.  Let’s look at what an NTI drug is […]

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01
Mar
AI Laws on the Move - Lachman Blog

AI Laws on the Move

Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]

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15
Feb

OGD Provides Update to Future Product Specific Guidances as Well as Planned Revisions 

Today, the FDA published a list titled Upcoming Product-Specific Guidances for Generic Drug Product Development, which can be found here and has two sections:  Planned New PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)  Planned Revised PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)  Section 1 contains a list […]

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25
Jan
The Court Case That Could Have Implications Beyond Its Borders - Lachman Blog

The Court Case That Could Have Implications Beyond Its Borders

This morning, when I read a Decision and Order issued by the United States Court of Federal Claims regarding a motion that was granted in part, denied in part, and filed on behalf of a pharmaceutical company and the FDA, the hair on the back of my neck stood on end. Now, I must state […]

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27
Dec
Benzene - Lachman Consultants Blog

Direct Final Guidance on Reformulating Drug Products Containing Certain Carbomers Manufactured with Benzene

The FDA’s action is being taken to address a safety issue associated with the need to reformulate drug products that contain carbomers manufactured with benzene. The goal is to expedite and provide a clear and less burdensome path than might otherwise be required under the applicable Scale Up and Post Approval Changes (SUPAC) guidances for […]

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19
Sep

FDA Changes Therapeutic Equivalence (TE) Code for Generic of Prograf 

In an alert yesterday from the FDA (here), the Agency indicated that it was changing the TE code of Accord Healthcare’s product (ANDA 091195) from AB (substitutable) to BX (“not sufficient information to demonstrate that Accord Healthcare Inc.’s tacrolimus oral capsules provide the same therapeutic effect as Prograf (tacrolimus) oral capsules”).  Tacrolimus is used for […]

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19
May

Petition Tests OGD Guidance on Use of Males and Females in BE Study

A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]

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