Search results for " FDA"
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Transformative Medicines Challenge FDA and Manufacturers
More controversial was FDA’s approval of Sarepta Therapeutics’ Exondys 51 (eteplirsen) to treat Duchenne muscular dystrophy, due to its reliance on an uncertain surrogate endpoint to demonstrate effic…
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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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FDA Approves First Biosimilar
The approval trails a unanimous positive vote in January 2015 from FDA’s Oncologic Drugs Advisory Committee. To date, there are a total of five 351(k) applications that are publicly disclosed, includi…
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FDA Framework Spurs Advanced Therapies
Three new products were approved in 2017 by FDA, chimeric antigen receptor (CAR) T-cell cancer therapies from Novartis and Kite Pharma and a retinal gene therapy from Spark Therapeutics. Markets and M…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“I think the FDA has been telegraphing what was going to be in these guidelines for some time now. They’ve been making presentations throughout last year at various industry conferences and they’ve pu…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
…consistent process control could stymie advancement in this field, cautions Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER). It’s “not simple” to bring a clinical p…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discusses the inclusion of a new FDA progr…
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Modern Manufacturing Systems Key to FDA Quality Initiative
To support real change, FDA’s Center for Drug Evaluation and Research (CDER) has launched a full-court press to convince industry of the value of adopting modern drug manufacturing systems. The agency…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pha…
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FDA Provides Guidance on Bispecific Antibody Development Programs
Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody development program,” the guidance document states.
The guidance may also apply to the …