Aktualności
FDA: ANDAs: Impurities in Drug Substances
16.07.2009
Food and Drug Administration (FDA) published Guidance for Industry which provides revised recommendations on what chemistry, manufacturing, and controls (CMC) information to include regarding the
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FDA: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act
16.07.2009
Food and Drug Administration (FDA) published draft Guidance, which provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C.
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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Draft guidance - comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the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
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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
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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
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