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Guide on ANDA In Vitro Permeation Studies

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled In Vitro Permeation Test Studies for Topical Products Submi...

ANDA Physicochemical/Structural Characterization Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Physicochemical and Structural (Q3) Characterization of Top...

Tremfya 80% Response Rate in Ulcerative Colitis: Janssen

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Janssen Pharmaceutical says new data show that patients given Tremfya (guselkumab) saw a clinical response rate of about 80% in tr...

FDA Explains Why Zepzelca Will Not be Withdrawn

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Responding to a petition seeking the removal of approval for Jazz Pharmaceuticals lung cancer drug Zepzelca, FDA explains why it d...

FDA Approves Biologic for Some Myelomas

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FDA gives accelerated approval to Janssens teclistamab-cqyv for some adults with relapsed or refractory multiple myeloma.

FDA Airs Daprodustat Safety Concerns

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FDA medical reviewers tell members of the Cardiovascular and Renal Drugs Advisory Committee there are safety concerns with GlaxoSm...

ANDA In Vitro Release Test Studies Guide

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Federal Register notice: FDA makes available a draft guidance entitled In Vitro Release Test Studies for Topical Products Submitte...

CGMP Violations at Nephron SC

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FDA warns West Columbia, SC-based Nephron SC about CGMP and other violations at its drug manufacturing facility.

Panel Reviewing Ipsen NDA Postponed

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FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and v...

CGMP, Other Violations at Advanced Cosmetic Lab

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FDA warns Chatsworth, CA-based Advanced Cosmetic Research Laboratories about CGMP violations and marketing of misbranded unapprove...