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RAPS: FDA Revises Guidance on Special Protocol Assessments

11.05.2016
The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and ...

RAPS: EMA Finalizes Process Validation Guidance

11.05.2016
The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, ...

RAPS: Genomic Data and Drug Development: EMA Offers New Draft Guidance

11.05.2016
As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and ...

GMP: EMA\'s new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers

11.05.2016
As referred to in the European Pharmacopoeia, the procedure for terminal sterilisation of a medicinal product, an API, or an excipient is generally the method of choice. Yet, this might be ...

GMP: EMA publishes finalised Process Validation Guideline for Biotech Products

11.05.2016
Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title ...

GMP: New FDA Draft Guidance \'Data Integrity and Compliance with cGMP\' published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 ...

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) ...

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 ...

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, ...

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 ...