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Guide on ANDA Facility Readiness and Goal Dates

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FDA posts a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.

Guide on Generic Drug Size and Shapes

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FDA releases a final guidance entitled Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.

Taiho Oncology Bile Duct Cancer Drug OKd

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FDA grants approval for a Taiho Oncology NDA for Lytgobi (futibatinib) for treating certain adult patients with bile duct cancer.

Lupin Gets Warning Letter After Inspection

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FDA sends India-based drug maker Lupin a Warning Letter after inspecting its Tarapur, Maharashtra facility 3/22 to 4/4.

CDER NextGen Portal Taking Certain OTC eSubmissions

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FDA expands CDERs NextGen Portal to enable certain electronic over-the-counter monograph submissions under section 505G of the Fed...

Increased Covid Risk For Those on Evusheld: FDA

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FDA adds important information to the emergency authorization of AstraZenecas Evusheld to inform health care providers and individ...

Early Reviews of Drug Master Files Cited in ANDAs

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FDA posts a draft guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA that introduces...

FDA Funds Biosimilar Research to Boost Development/Review

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FDA awards the Biologics & Biosimilars Collective Intelligence Consortium a $1.3 million grant to support biosimilars research and...

GE Healthcare Gets AIR Recon Imaging Clearance

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FDA clears a GE Healthcare 510(k) clearance for its AIR Recon DL for 3D and Propeller imaging sequences for use during magnetic re...

BioMarin Refiles BLA for Hemophilia Gene Therapy

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BioMarin refiles its BLA for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A.