Search results for "New drug"
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Quality Systems Key to Lifecycle Drug Management
In most situations it’s easier to design a new drug than to update existing analytical methods and technology, noted Ganapathy Mohan, head of global CMC at Merck, Sharp and Dohme. Global approval of a…
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Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
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Drug Discovery and Development in India
In May 2012, Ranbaxy Laboratories launched Synriam (arterolane maleate plus piperaquine phosphate), a new drug for the treatment of uncomplicated Plasmodium falciparum malaria. Similarly, Cadila Healt…
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New Era for Generic Drugs
Former FDA officials recalled the challenges in establishing new policies for testing and evaluating generic medicines and how the program’s success has generated thousands of abbreviated new drug app…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Such team efforts have been particularly effective for analyzing new COVID-19 vaccines and therapies, as well as for timely review of the steady stream of new drug applications (NDAs), biologics licen…
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FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
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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…
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Manufacturers Struggle with Breakthrough Drug Development
It’s a sign of strong industry interest in developing new drugs with accelerated, abbreviated pathways, even if indicated for small patient populations.
Janet Woodcock, director of the Center fo…
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Breakthrough Drugs Raise Development and Production Challenges
Nearly 15 important new therapies have come to market more quickly as a result, contributing to the recent rise in new drug approvals. FDA acting commissioner Stephen Ostroff pointed out at the annual…
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Global Expansion Shapes Drug Oversight
…t program that allows for parallel review and consultation on quality-by-design (QbD) components to new drug applications and supplements, an initiative designed to provide consistency and clarity to…