Generics

27
Mar

Face to Face Meetings at OGD – Get in Line and Get Ready!

That’s right! Get ready, get set, GO! Beginning March 27, 2023, OGD will start to accept requests for Face to Face (FTF) meetings again. However, according to the FDA announcement, FTF meetings will be limited to “pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.” Access may […]

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15
Mar

Q1 & Q2 Differences Between RLD and Proposed Generic May Get Help from Legislation

Yesterday, “U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH), both members of the Health, Education, Labor, and Pensions Committee, reintroduced bipartisan legislation to streamline the approval process for generic medications, which are often significantly cheaper than their brand-name counterparts” says a release from Senator Paul’s office (here).  If passed, the bill would direct the […]

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10
Mar

FDA 2024 Budget Proposal Proposes Fix to the “Skinny” Label Issue

The FDA released its proposed budget and legislative proposals for FY 2024 (summary can be found here).  Besides certain requests for additional funding, reauthorization of the user fee programs for new and abbreviated animal drug programs, a host of safety issues, as well as new record retention requirements to fight data integrity problems in applications and […]

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06
Mar

January 2023 Official Statistics – and Yes, I Am a Bit Confused

When we reported the unofficial January approval actions in a previous blog post,  there was some concern about how OGD would be reporting their approval and tentative approval actions on the daily report versus the Generic Drugs Program Monthly and Quarterly Activities Report (here). If you go back and read the January unofficial approval blog […]

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03
Mar

REMS Bill – Is It Really the Answer?

The Hill report (here) that “Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.”  The bill would permit FDA to approve a drug product for a generic immediately if all other approval requirements are […]

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21
Feb

New GFI- PSG Meetings between FDA and ANDA under GDUFA

We have seen several changes from FDA with the roll-out of GDUFA III.  Some have been a little frustrating (Controlled Correspondence blog coming soon!), but some have been pretty great!  On February 17, 2023 FDA issued a new GFI, “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA” (here). This GFI seems to point […]

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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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