05
Oct

The State of Biosimilars and Generics 2023

The title of this blog was also the title of the presentation given by Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research.  I just could not think of a better title!  It is like the State of the Union address but not as expansive.  Dr. Corrigan-Curay spoke to the […]

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02
Oct

OGD Expands FTF Meeting Options – Announcement Just Prior to AAM’s GRx+Biosims Meeting

According to the Office of Generics Drugs (OGD) September 29, 2023 announcement (here) on October 2, 2023 OGD will expand the types of face-to-face (FTF) meeting it will entertain. That is of course, if the government does not shut down on Sunday October 1, 2023. Prior to this announcement, and after the Covid emergency was […]

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29
Sep
FDA Provides Annual Forecast Activities for Various OTC Monographs -Some Surprises Here_LachmanConsultants

FDA Provides Annual Forecast Activities for Various OTC Monographs -Some Surprises Here!

The FDA notice (here) states: “[T]he over-the-counter (OTC) monograph annual forecast is a nonbinding list, issued each year, of planned monograph activities that FDA intends to initiate over the ensuing 3 years.” When the new monograph system went into effect, it was designed to reduce time to decision making by eliminating the lengthy comment and […]

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27
Sep

Mullin and Booker Introduce Bill for e-labeling – New Round Begins

Senator Mullin and Booker yesterday introduced a bill (here ) to permit e-labeling (electronic package inserts) to eliminate paper waste and permit firms to provide the most updated information almost instantaneously.  There was also a press release (here ) that explained once more what has been explained a number of times in the past. This […]

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20
Sep

Bipartisanism Shows up at House Hearing on PBMs

Yesterday, the Committee on Oversight and Accountability of the House of Representatives issued a press release (here) after the hearing on Pharmacy Benefits Managers (PBMs) and their impact on drug pricing.  The press release is titled “Hearing Wrap Up: Pharmacy Benefit Managers Push Anticompetitive Drug Pricing Tactics to Line Their Own Pockets.”  I guess this […]

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15
Sep
If You Are Looking for ANDA Approvals for September, Be Patient - Lachman Consultants

If You Are Looking for ANDA Approvals for September, Be Patient

This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today! As I mentioned in that blog post, this problem […]

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