News
RAPS: FDA Plans to Fund Research on Generic Drug Efficacy, Medical Countermeasures and More
19.03.2015
The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways
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Asia Regulatory Roundup: China Rolls out New Clinical Practice Rules (24 February 2015)
19.03.2015
China Food and Drug Administration’s (CFDA) recently introduced draft good clinical practices (GCPs) will clarify the process for outsourcing to contract research organizations (CROs),
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FDA: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
12.03.2015
This guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health
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EMA: Regulatory information - EMA introduces weekly start dates for the assessment of type II variations from March 2015
12.03.2015
The new timetables are expected to increase submission flexibility and streamline assessment of applications. From March 2015, the European Medicines Agency will introduce weekly start dates to
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EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
12.03.2015
This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked
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RAPS: The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech
12.03.2015
Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost
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MHRA: An innovative approach to developing malaria vaccine
12.03.2015
The Medicines and Healthcare products Regulatory Agency (MHRA) has today published its fourth case study detailing how the regulator has helped researchers at the Jenner Institute, University of
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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 4, 2015 on the amendment of change the granted period of initiation of the DCP / MRP of the Polish Republic as the refere
12.03.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 4, 2015 on the amendment of change the granted
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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 4, 2015 on the accession the Voluntary Harmonization Procedure (VHP) in clinical trials.
12.03.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 4, 2015 on the accession the Voluntary
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FDA: Complicated Urinary Tract Infections: Developing Drugs for Treatment, Guidance for Industry
05.03.2015
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses the
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