Aktualności

FDA: Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

14.07.2009

Draft guidance - comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the ...

EMEA: Note for Guidance on Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions

13.07.2009

International Committee for Harmonization guidance has been published - ICH Topic E16, Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions. ...

FDA: Facts and Myths about Generic Drugs

10.07.2009

Today, 7 in 10 prescriptions filled in the United States are for generic drugs. This fact sheet explains how generic drugs are made and approved and debunks some common myths about these products. ...

EMEA: Human Medicines - EMEA’s interaction with healthcare professionals’ organisations

10.07.2009

Information on benefit-risk of medicines: patients’, consumers’ and healthcare professionals’ expectations. ...

Polish Ministry of Health: Regulation project on the classification of drug products, which can be sold outside pharmacies.

09.07.2009

Polish Ministry of Health: Regulation project on the classification of drug products, which can be sold outside pharmacies. ...

EMEA: Opinions and decisions on PIP applications

09.07.2009

EMEA decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP. ...

ICH: Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter

06.07.2009

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the ...

ICH: Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Sterility General Chapter

06.07.2009

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the ...