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RAPS: FDA Warns Teva’s Banned Hungary Manufacturing Facility

17.11.2016
The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as ...

RAPS: EMA Transparency: New Clinical Reports Go Live

17.11.2016
The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a ...

EMA: EMA encourages companies to submit Type I variations for 2016 by end of November

17.11.2016
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to ...

EMA: Revising the guideline on first-in-human clinical trials

17.11.2016
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human ...

GMP: FDA´s Drug Safety Draft Guidance regarding REMS

17.11.2016
On September 20, 2016, the Food and Drug Administration (FDA) published a draft guidance for industry on the "Application of Statutory Factors in Determining When a REMS Is Necessary" ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN for veterinary medicinal products

17.11.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of October 13, 2016 on verification and additions EAN / GTIN ...

GMP: GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers

25.10.2016
The GDUFA (Generic Drug User Fee Amendments) is a legislative package which came into force in 2012 and entitles the US-American FDA to collect fees from generic drug manufacturers, who ...

GMP: WHO publishes Second Draft of a Global Medical Devices Regulation

25.10.2016
With a draft document made up of 66 pages, the WHO intends to provide support regarding the introduction and implementation of regulations with regard to medical devices, including in vitro ...

GMP: MHRA publishes Draft Guidance on "Usability" of Medical Devices

25.10.2016
With its new draft guidance on human factors and usability requirements, the MHRA is giving greater emphasis to design process in the development of medical devices and combination products - ...

RAPS: FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers

25.10.2016
The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing ...