Bioequivalence

22
Oct
The sun's up and so is my mood

AAM Brief Look Back at Day One and Some Thoughts on Day Two

My fingers were tired last night so I did not get to capture a highlight of the presentation made by Dr. Iilun Murphy, Director, Office of Generic Drugs, which is usually one of the biggest draws of this annual conference.  So, let’s take a step back and provide you with some tidbits from her presentation. […]

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02
Oct
Question Marks on Blackboard

FDA Knew There Would Be Questions – Soon, You Can Ask Them! 

On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here).  One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral […]

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20
Sep
OGD Effort to Comply with ICH M13 in High Gear – Drops Fed Study Requirements for Hundreds of Products - Lachman Blog

OGD Effort to Comply with ICH M13 in High Gear – Drops Fed Study Requirements for Hundreds of Products

Historically, and in most cases, industry knows that it will certainly be required to perform both fasting and fed bioequivalence studies on solid oral immediate-release products or it may have an option to seek a waiver of in-vivo bioequivalence requirements for BCS Class 1 drugs. However, a few days ago, the FDA published a listing of […]

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09
Sep
Scientist working doing some research at a laboratory

Does Testing into Compliance Just Apply to Sample Release Test Data?

The WHO has a draft July 2013 guidance document titled “Deviation Handling and Quality Risk Management” that addresses the concept that not all Quality Events are equivalent and provides consideration for the classification of events.  For example, an incident would be an event that does not: “…affect a product attribute, manufacturing operational parameter or the […]

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23
Aug
Businessman Signing Legal Paper In Office

New and Revised PSGs – Time to Check Your Portfolio!

Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA’s current thinking on the requirements for bioequivalence testing for generic drugs (here).  In addition, the FDA updated its list of planned PSG issuances (73 new PSGs) as well as the list of PSGs that it […]

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20
Aug
Science versus Compliance - Lachman Blog

Science versus Compliance?

Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated. Two examples of what can be heard: “Oh well, that is more of a compliance risk than a scientific concern.” “You need to consider the compliance aspect of that change and then the scientific […]

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19
Aug
Pre- and Post-PSG Telcons, Meetings Outlined in New Final FDA Generic Guidance - Lachman Blog

Pre- and Post-PSG Telecons, Meetings, Etc. Outlined in New Final FDA Generic Guidance

Today, the FDA released a final guidance titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (here). Wading through the 26-page document is a bit of a chore, but there is a lot of useful information that will provide applicants with advice on what to do, when to do it, and how to […]

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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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