Regulatory Roundup: Week of October 15, 2012 - Pharmaceutical Technology

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Regulatory Roundup: Week of October 15, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency has opened public consultation on the revised CHMP Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Acute Heart Failure (CHMP/EWP/2986/03 Rev.1).

EMA also released its guideline on medicinal products for the treatment of schizophrenia on Oct. 9, 2012. The guideline describes requirements for the development of medicinal products with regard to study design, patient population, and outcome measures and goes into effect on Apr. 1, 2013.

FDA has collected generic drug information and made it available on their website for industry. The website include guidance document updates, recent meeting minutes, reports, and other relevant information.

Recent guidance documents published by FDA include E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. Questions and Answers (R1) (October 2012). A comprehensive list of FDA guidance documents can be found on and well as a list of withdrawn guidance documents.

The Orange Book, the Approved Drug Products with Therapeutic Equivalence Evaluations, has been updated with additions and deletions of prescription and OTC products.

The International Conference on Harmonization has released the final meeting report from the latest Global Cooperation Group meeting held in Fukuoka, Japan on June 5, 2012.


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