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EMA: Guideline on the acceptability of names for human medicinal products processed through the centralised procedure

05.06.2014
This 6th update of the guideline further clarifies specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues and ...

RAPS: FDA Classifies Cellulite-Reducing Device as Class II

05.06.2014
The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve \"the appearance of cellulite\" as Class II medical devices, making it ...

EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

05.06.2014
The guideline addresses the requirements regarding manufacturing processes, the biosimilar comparability exercise for quality, considering the choice of reference medicinal product, analytical ...

RAPS: India Issues Final Rule on Compensating Clinical Trial Deaths

05.06.2014
India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be ...

RAPS: FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes

05.06.2014
The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted ...

EC: EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use

29.05.2014
Volume 2 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 ...

RAPS: Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

29.05.2014
The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its \"Unified Agenda,\" outlining six new rules it says it intends to ...

EMA: European Medicines Agency welcomes publication of the Clinical Trials Regulation

29.05.2014
The European Medicines Agency (EMA) welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union (EU). This legislation will open up a new era for the ...

EMA: Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products

29.05.2014
The currently approved ‘guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products’ came into operation in January 2005. Since then, new fibrin sealant ...

EMA: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)

22.05.2014
This guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are ...

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