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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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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07
Feb

Join Lachman Consultants at Access!™ AAM Annual Meeting 2023

Visit with Lachman Consultants in Griffin Foyer, Booth #4 at the AAM Annual Meeting. Lachman Consultants is a proud Business Exposition Sponsor of this yearly event that’s taking place at the JW Marriott Orlando Bonnet Creek Resort & Spa in Orlando Florida on February 13th-15th, 2023.  Access!™ is where policymakers, influential speakers and industry leaders […]

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06
Feb

January 2023 Unofficial Approval Actions and an Explanation!

As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals.  What the heck does that mean?  Well, let’s take an example from this month’s approval actions.  On January 24, 2023, the OGD approved one fentanyl application; however, that single application had […]

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30
Jan

Petition Requests Removal of Generic Tasimelteon from the Market for Lack of Braille on Its Label

This is something I have not come across in over fifty years in the pharmacy and pharmaceutical business!  The issue is related to a drug product called Hetlioz (tasimelteon) capsules, marketed by Vanda.  The product is indicated for non‑24‑hour sleep‑wake disorder (non‑24) and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) in children and adults.  The […]

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20
Jan

Quarterly Reporting Requirements for Priority Review Applications and Competitive Generic Therapy Posted Today

As the FDA notes, “Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy (CGT) designation under section 506H of the FD&C […]

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