News
EDQM: Heparin: NMR Test Protocol for OSCS determination in API Heparin Sodium and Calcium
30.01.2009
EDQM:
Heparin: NMR Test Protocol for OSCS determination in API Heparin Sodium and Calcium
The purpose of this document is to provide to all users of the European Pharmacopoeia ...
Heparin: NMR Test Protocol for OSCS determination in API Heparin Sodium and Calcium
The purpose of this document is to provide to all users of the European Pharmacopoeia ...
European Commission: Public consultation on revisions of GMP Annex 14 on \"Manufacture of medicinal products derived from human blood or plasma”
30.01.2009
European Commission:
Public consultation on revisions of GMP Annex 14 on \"Manufacture of medicinal products derived from human blood or plasma”. It applies to medicinal products ...
Public consultation on revisions of GMP Annex 14 on \"Manufacture of medicinal products derived from human blood or plasma”. It applies to medicinal products ...
MHRA: Global shortage of acetonitrile: Advice to the pharmaceutical industry on changes requiring variation submissions to update Marketing Authorisations
30.01.2009
MHRA:
Global shortage of acetonitrile: Advice to the pharmaceutical industry on changes requiring variation submissions to update Marketing Authorisations. There is currently a global ...
Global shortage of acetonitrile: Advice to the pharmaceutical industry on changes requiring variation submissions to update Marketing Authorisations. There is currently a global ...
EMEA: COMP Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation
30.01.2009
EMEA:
Committee for Orhphan Medicinal Products Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation ...
Committee for Orhphan Medicinal Products Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation ...
EMEA: List of questions & answers (Q&A) received during the HMPC assessors training on quality issues emerging for herbal medicinal products
30.01.2009
EMEA:
List of questions & answers (Q&A) received during the Committee on Herbal Medicinal products (HMPC) assessors training on quality issues emerging for herbal medicinal products (held ...
List of questions & answers (Q&A) received during the Committee on Herbal Medicinal products (HMPC) assessors training on quality issues emerging for herbal medicinal products (held ...
EMEA: Draft EudraVigilance access policy for medicines for Veterinary use
30.01.2009
EMEA:
Draft EudraVigilance access policy for medicines for Veterinary use. This document should serve as a starting point for the elaboration of EudraVigilance access policies and the ...
Draft EudraVigilance access policy for medicines for Veterinary use. This document should serve as a starting point for the elaboration of EudraVigilance access policies and the ...
FDA: Guidance for Industry - Labeling OTC Human Drug Products – Questions and Answers
30.01.2009
FDA:
Guidance for industry - Labeling OTC Human Drug Products – Questions and Answers. This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter ...
Guidance for industry - Labeling OTC Human Drug Products – Questions and Answers. This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter ...
FDA: Comprehensive List of Guidance Documents
30.01.2009
FDA:
Center For Drug Evaluation and Research - Comprehensive List of Guidance Documents ...
Center For Drug Evaluation and Research - Comprehensive List of Guidance Documents ...
FDA: Guidance for Industry - Annex 2 Test for Extractable Volume of Parenteral Preparations General Chapter
30.01.2009
FDA:
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 2 Test for Extractable Volume of Parenteral Preparations General ...
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 2 Test for Extractable Volume of Parenteral Preparations General ...
FDA: Guidance for Industry - Annex 3 Test for Particulate Contamination: Subvisible Particles General Chapter
30.01.2009
FDA:
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 3 Test for Particulate Contamination: Subvisible Particles General ...
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 3 Test for Particulate Contamination: Subvisible Particles General ...