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GMP: FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices

06.07.2011
The aim of the new Guidance is to inform reviewers - in the premarket application process for medical devices (510k, PMA, HDE processes) and for clinical studies (IDE process) - about the latest ...

GMP: Directive 2011/62/ of the European Parliament on the Community code relating to medicinal products for human use

01.07.2011
Directive 2011/62/ of the European Parliament and of the council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the ...

FDA: Q11 Development and Manufacture of Drug Substances

28.06.2011
This guideline describes approaches to developing process and drug substance 66 understanding and also provides guidance on what information should be provided in 67 CTD sections 3.2.S.2.2 – ...

GMP: New ICH Q11 Guideline published

21.06.2011
On June 16, 2011 the ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) was published as a Step 3 document This ...

FDA: Guidance for Industry Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics

16.06.2011
The purpose of this guidance is to provide recommendations to applicants on endpoints for non¬21 small cell lung cancer (NSCLC) clinical trials submitted to the Food and Drug Administration 22 ...

EMA: Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance

06.06.2011
This concept paper addresses the need to develop guidance on process validation of biotechnology derived active substances. ...

MHRA: More exact paracetamol dosing for children to be introduced

06.06.2011
Updated dosing for children’s liquid medicines containing paracetamol has been developed to ensure children get the most effective amount, and to support giving it to them in the best way. The ...

EMA: Concept paper on the revision of the guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal product

01.06.2011
This concept paper is concerned with the revision of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal ...

EMA: European Medicines Agency and Heads of Medicines Agencies propose measures to make information in application dossiers more transparent

01.06.2011
The European Medicines Agency and the Heads of Medicines Agencies (HMA) have released a guidance document on the identification of commercially confidential information and protection of personal ...

EMA: Standard operating procedure for internal audit conducted by the internal audit service

19.05.2011
This SOP describes the procedure for internal audits: including planning, conduct, communication, contradictory procedure, quality assessment, final report, action plan and any follow-up actions ...