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RAPS: FDA Revises Labeling Guidance to Clarify Clinical Pharmacology Recommendation

14.08.2014
A new draft guidance document published by the US Food and Drug Administration (FDA) seeks to help sponsors with the \"clinical pharmacology\" sections that accompany an approved drug\'s labeling. ...

EMA: Draft reflection paper on classification of advanced-therapy medicinal products

07.08.2014
This reflection paper has been updated to reflect the current thinking of the Committee on Advanced Therapies (CAT) on substantial manipulation and non-homologous use. Additional changes have been ...

EMA: Draft reflection paper on the use of cocrystals and other solid-state forms of active substances in medicinal products

07.08.2014
The content of this reflection paper represents the current thinking of the Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working ...

EMA: Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies

07.08.2014
The importance of the patient’s point of view on their health status is fully acknowledged and such information may in principle be used in drawing regulatory conclusions regarding treatment ...

EMA: Europe to boost cooperation with international partners on generics

07.08.2014
The European Union (EU) is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the ...

EMA: User guide for micro, small and medium-sized enterprises

07.08.2014
This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal ...

GMP: European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

31.07.2014
In this release, the Commission explains their approach with regard to the integration of the content of ICH Q3D in the European Pharmacopoeia. ...

RAPS: FDA Issues Guidance on \'Substantial Equivalence\' Process Used to Bring Devices to Market

31.07.2014
The US Food and Drug Administration (FDA) has issued an extensive and long-awaited guidance document on its premarket notification program—also known as the 510(k) pathway—detailing how ...

EMA: Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)

31.07.2014
The Pharmacovigilance Risk Assessment Committee (PRAC) has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, and ...

FDA: Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

24.07.2014
This interim guidance describes FDA’s expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with ...

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