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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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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16
Apr

FDA SBIA Generic Drug Forum 

What is the answer to the question?  Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC).  The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout […]

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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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18
May

FDA Releases New and Revised BE Product Specific Guidances

Today, the FDA released another batch of Product‑Specific Guidances (PSGs), outlining its current thinking on the bioequivalence (BE) testing requirements for generic products – twenty‑five new BE guidances and twenty‑one revised guidances.  The listing can be found here. The FDA has various goals regarding publication of these PSGs that are tied to getting information to […]

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