Generics

07
May
April 2025 Unofficial ANDA Approvals and Delay in Official Stat Postings - Lachman Blog

April 2025 Unofficial ANDA Approvals and Delay in Official Stat Postings

While we were able to piece together the April 2025 unofficial approval picture, we need to note that it has now been over three months since any official statistics from the Generic Drugs Program Monthly and Quarterly Activities Report have been published publicly (see here). This is a bit discouraging, but not totally unexpected, after […]

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22
Apr
Compiling a thorough plan towards her patient's healing

GDUFA III and DMF Assessments

On Day 2 of the Generic Drugs Forum (GDF), there were a couple of sessions on Drug Master Files (DMFs) that provided some helpful information.  The first presentation, from Dr. Jayani Perera, Senior Chemist in the Division of Product Quality Assessment (DPQA) XIX, provided some insight into the GDUFA III impact on DMF Assessments and DMF Prior Assessments (watch […]

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21
Apr
A Peek at Mid-April 2025 Unofficial ANDA Approval Actions - Lachman Blog

A Peek at Mid-April 2025 Unofficial ANDA Approval Actions

With the first (albeit unofficial) count of ANDA approval actions since the layoffs at the OGD, the future does not appear bleak. At least not yet! The postings through April 16th for approval actions show that the OGD has issued 43 full-approval actions and five tentative-approval actions for a mid-month total of 48 approval actions, which […]

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18
Apr
The Countdown to Nitrosamine Impurity Compliance - Lachman Blog

The Countdown to Nitrosamine Impurity Compliance in the U.S. Has Begun

Lachman has blogged many times on the topic of nitrosamines over the last several years as the FDA has issued and revised guidances providing its recommendations for assessment and control of nitrosamine impurities. The published deadline for compliance with these recommendations is quickly approaching; it’s just over three months until the August 1, 2025 compliance date […]

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17
Apr
Asking FDA to Take Another Look - What’s New with RfR - Lachman Blog

What’s New with Requests for Reconsideration?

On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin […]

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14
Apr
Imminent Actions Discussed at Generic Drug Forum - Lachman Blog

Imminent Actions Discussed at Generic Drug Forum, with Clarity on IA Report Metric!

It has been quite some time since issuance of the GDUFA III commitment letter, which discussed a few new enhancements to the ANDA review and approval process, among other things. One such enhancement was Imminent Action (IA). Just to refresh your memory, an imminent action is an extension of the goal date when the Office of […]

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11
Apr
Game Show Winner

Is the “Price Is Right” Game Over for Many Generic Drugs?

On April 10, U.S. Senators Maggie Hassan (D-NH), Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Lee (R-UT) reintroduced bipartisan legislation S. 1302 that would prevent the FDA and industry from participating in a protracted guessing game regarding the amount of an inactive ingredient for a subset of generic drugs that are either required by regulation […]

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