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1. Rx Price Watch report: retail prices for widely used brand name drugs increase considerably prior to generic competition


2. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use


4. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders


5. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff


6. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)


8. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance


9. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases


10. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter