Orphan drugs Archives - Lachman Consultant Services, Inc.

CBER Orphan Drug Approvals for 2023

By Bob Pollock Dec 19, 2023 Biologics BLA Orphan drugs

According to an updated post on the Center for Biologics Evaluation and Research (CBER) webpage, there were twelve Biologics License Applications (BLAs) approved for products that had orphan drug (OD) status. Just to cite a few: Two were for treatment of sickle cell disease (SCD). One was for enzyme replacement therapy (ERT) in adult and […]

Oct

Slicing the Bologna Too Thin Leads to Appeals Court’s Overturning District Court’s Ruling – Harkens Back to Skinny Label in Recent “Inducement to Infringe” Decisions – I’m Confused

By Bob Pollock Oct 01, 2021 FDA Generics Orphan drugs Regulatory Affairs

Everyone knows that I am not a lawyer; I’m just a regulatory geek. But in the case of Catalyst Pharmaceuticals v. FDA and Jacobus in an orphan drug dispute, where the case rested on whether the phrase “same disease or condition” is ambiguous, there are few things that confuse me. The central issue is the […]

Orphan drugs

CBER Orphan Drug Approvals for 2023

Slicing the Bologna Too Thin Leads to Appeals Court’s Overturning District Court’s Ruling – Harkens Back to Skinny Label in Recent “Inducement to Infringe” Decisions – I’m Confused

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