News
RAPS: Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance
19.04.2016
The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft
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RAPS: FDA Offers Specific Guidance on Bioequivalence Trials for Next Generation of 38 Generic Drugs
19.04.2016
The US Food and Drug Administration (FDA) on Thursday unveiled 38 new specific recommendations on the types of bioequivalence trials generic drug companies should run in order to win approval for
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RAPS: Final FDA Guidance on Drug Design Seeks to Reduce Medication Errors
19.04.2016
The US Food and Drug Administration has finalized guidance detailing best practices on how to improve a drug\'s container closure system to minimize the risk of medication errors. Medical errors,
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GMP: Monoclonal antibodies as similar biotherapeutic products - Draft Guideline
19.04.2016
On 1 March, the World Health Organization (WHO) published a new guideline draft on the evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). This product specific document
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FDA: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information
19.04.2016
This guidance provides recommendations to holders of applications for human drugs and biologics on implementing a chemistry, manufacturing, and controls (CMC) postapproval change through the use
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FDA: Data Integrity and Compliance With CGMP
19.04.2016
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers
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EMA: Promoting high-quality clinical research to develop more and better medicines for children
19.04.2016
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its 8th annual workshop on 2 June 2016 at the premises of the European Medicines Agency (EMA) in
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EFSA: Public consultation on the draft scientific opinion on dietary reference values for vitamin D
04.04.2016
EFSA has launched an open consultation on its draft scientific opinion on dietary reference values for vitamin D. This document proposes dietary reference values for vitamin D for adults, infants
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RAPS: India Releases New Biosimilars Guidance
04.04.2016
India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India\'s
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RAPS: FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling
04.04.2016
The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry
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