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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08
Oct

Signs of Progress on the Nitrosamine Front – Notes from the Nitrosamines Session at GRx+Biosims 2023 

The session on nitrosamine impurities was held during the final breakout session on Wednesday morning during the final day of the conference. This session had the largest panel by far of those assembled on any topic presented at the conference, with 15 total panelists including the session moderator!  It was even more difficult than usual […]

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25
Aug
Pitfall-Journey_blog_LachmanConsultants

Surviving the Perils of Submitting Controlled Correspondences (Part 2)

In Part 1, we focused on drafting the Controlled Correspondence and tips for formatting and presenting the correspondence, but, after submission, the CC must be accepted by the coordinator to be placement in the queue for review. The office has been very strict, perhaps rightly so, but there have been a few headscratchers too. Some examples […]

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24
Aug
Pitfall-Journey_blog_LachmanConsultants

Surviving the Perils of Submitting Controlled Correspondences (Part 1)

Of the many benefits that have come from the Generic Drug User Fee Act (GDUFA) over the years, one has been the addition of response times for the FDA to answer Controlled Correspondences (CCs) that were first negotiated under GDUFA II. The Agency issued an FDA CC guidance, which was finalized in December 2020. Having a […]

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17
Aug

The Curious Case of the LateCycle Amendment under GDUFA III

Many of our blog readers have likely encountered moving goal dates for their ANDAs since October 1, 2022 and the beginning of GDUFA III.  The GDUFA III Commitment Letter, available here, included several new enhancements to the generic drug user fee program as each iteration of the program has continued to do.  The changes made to promote transparency […]

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16
Feb
Updates from Access! AAM Annual Meeting 2023 - Lachman Consultants

FDA Updates from Access! AAM Annual Meeting 2023

Hello from sunny Orlando and the AAM annual meeting!  The FDA’s Jacqueline Corrigan-Curay, Principal Deputy Director, CDER, FDA, had the honor of providing the FDA’s keynote address.  She started her talk by highlighting some of the accomplishments of GDUFA II, such as calling out the 490 first-generic approvals and 553 complex-generic approvals out of a total […]

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11
Nov

Nitrosamines – Where Are We Now?

Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned?  That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference.  The session devoted […]

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