Aktualności
GMP: New FDA Draft Guidance \'Data Integrity and Compliance with cGMP\' published
11.05.2016
In recent years, the topic \"data integrity\" has become a priority for European and American inspectors. At the beginning of 2015, the British authority MHRA published a first paper on that
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FDA: Special Protocol Assessment Guidance for Industry
11.05.2016
This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 13, 2015 on the implementation of the Ordinance delegated Regulation (EU) 2016/161 of October 2, 2015 supplementing Directi
19.04.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 13, 2015 on the implementation of the Ordinance
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RAPS: Generic Drug Approvals Hit New Record in 2015, FDA Report Shows
19.04.2016
The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017,
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RAPS: Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance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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