Search results for " drug manufacturing"
Article
Quality Systems Key to Lifecycle Drug Management
…oval changes leads to unnecessary submission of supplements and discourages continual improvement in drug manufacturing processes.
OPF acting director Christine Moore noted that differing change f…
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Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
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Drug Quality Key to Innovation and Access
Manufacturing challenges
Accelerated FDA approval of important therapies demands drug manufacturing systems able to scale up production quickly and efficiently and to maintain quality throughout th…
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FDA Seeks Metrics to Define Drug Quality
Seeking metrics
In crafting the shortages plan, an FDA Drug Shortages Task Force has been examining more broadly how drug manufacturing problems may precipitate plant closings and product discontin…
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New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue …
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Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA pro…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
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Drug Discovery and Development in India
…ment of Pharmaceuticals Pharma Vision 2020 (7), which is designed to make India a hub for end-to-end drug manufacturing. He says, “To encourage greater participation from industry players, the govern…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
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Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …