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MHRA: Adverse drug reaction (ADR) reports received by the MHRA from literature articles

27.07.2009
This section provides a list of UK spontaneous adverse drug reaction (ADR) reports based on articles from the scientific literature. The list is updated daily and provides the MHRA ADR reference ...

Polish Ministry of Health: The project of Act of the Pharmaceutical law

23.07.2009
Polish Ministry of Health published the amendment of Act of the Pharmaceutical law. Comments for this act can be apply till 18 of August. ...

EDQM: Actions taken by the EDQM.

22.07.2009
The EDQM announces the suspension of the following CEPs. ...

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 ...

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Food and Drug Administration (FDA) published draft Guidance, which provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. ...

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Draft guidance - comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing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