Search results for " drug evaluation"
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Drug Quality Key to Innovation and Access
These issues were highly visible in the debate over FDA approval of Sarepta Therapeutics’ treatment for Duchenne muscular dystrophy; reviewers and senior staffers in the Center for Drug Evaluation and…
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Quality Systems Key to Lifecycle Drug Management
The review of manufacturing supplements by the Center for Drug Evaluation and Research (CDER) has increased over the past decade, partly due to the practice of “locking in” an applicant’s manufacturin…
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New Era for Generic Drugs
One result is the elevation of the relatively small Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) into a “super office” to accommodate a larger cadre of scientist…
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FDA Seeks Metrics to Define Drug Quality
Despite a decade of encouragement and guidance from FDA, manufacturers have failed to adopt a “continuous improvement model,” according to Janet Woodcock, director of the Center for Drug Evaluation an…
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Manufacturers Struggle with Breakthrough Drug Development
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), is excited about the emergence of many new drugs “with incredible efficacy for certain subgroups,” but acknowledged that…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
One result is that drug approval processes for fiscal year 2021 remained
strong, with 53 novel drugs approved by the Center for Drug Evaluation and Research (CDER) as of Sept. 30, 2021. That i…
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Breakthrough Drugs Raise Development and Production Challenges
Expert review teams in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are meeting deadlines and goals for assessing breakthrough designa…
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Global Expansion Shapes Drug Oversight
And last month, Howard Sklamberg, deputy commissioner for Global Regulatory Operations and Policy (GO), Janet Woodcock, director of the Center for Drug Evaluation and Research, and Karen Midthun, dire…
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…