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FDA: FDA Guidance for Industry: Electronic Source Data in Clinical Investigations

10.07.2014
This new FDA Guidance defines the FDA\'s expectations for sponsors, CROs, investigators and other persons involved in the capture, review and retention of electronic source data generated in the ...

EMA: Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products

10.07.2014
This document applies to the follow-up of pharmacovigilance inspections of MAHs with centrally authorised products (CAPs) and nationally authorised products (NAPs) including those authorised via ...

RAPS: FDA Outlines Regulatory Approach for Nanotechnology

10.07.2014
The US Food and Drug Administration (FDA) has finalized a 2011 guidance document outlining its regulatory approach for nanotechnology products, including medical products. ...

GMP: APIC publishes Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants

18.06.2014
An APIC multinational working group has compiled a new guidance on cleaning validation with the title \"APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients ...

EC: EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use

18.06.2014
Volume 6 of the publications \"The rules governing medicinal products in the European Union\" contains a list of regulatory guidelines related to procedural and regulatory requirements such as ...

EMA: European Medicines Agency selects first two medicines to be included in its adaptive licensing pilot project

18.06.2014
The European Medicines Agency has received 20 applications so far as part of its adaptive licensing pilot project. Following an in-depth review of nine of these applications, the Agency has ...

GMP: Authority uses Margin of Interpretation regarding Qualification as QP

18.06.2014
The Danish Health and Medicines Authority (DHMA) has published a document which shows that the EU has left enough leeway for the implementation of EU directives. This could be an option in other ...

RAPS: FDA Adopts, Releases ICH Document on Dose Uniformity

18.06.2014
The US Food and Drug Administration (FDA) has adopted and released a new guidance document intended to clarify the International Conference on Harmonisation\'s (ICH) Q4B guideline on the use of ...

Polish Ministry of Health: The Regulation of Polish Minister of Health of April 18, 2014 concerning detailed manner of presenting the dossier for application for marketing authorization of the medicinal product

12.06.2014
This document is a regulation of Polish Minister of Health concerning the detailed manner of presenting the dossier for application for marketing authorization of the medicinal product. Full text ...

FDA: Draft Guidance - Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

12.06.2014
This draft guidance is intended to assist spon sors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to ...

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