Drug Regulators, EMEA, Publish ICH Q4B, Annex 10, Polyacrylamide Gel Electrophoresis General Chapter Guidance
Filed in manufacturing, December 31, 2009, 10:54 amThis annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Regulators, EMEA, Publish Draft Guidance on Validation of Bioanalytical Methods
Filed in clinical, , 10:32 amMeasurement of drug concentrations in biological matrices is an important aspect of medicinal product development for those products containing new active substances as well as for line extensions and generic products.
Drug Regulators, EMEA, Publish Guidline on Xenogenic Cell-Based Medicinal Products
Filed in clinical, manufacturing, , 8:56 amXenogeneic cell-based therapy is the use of viable animal somatic cell preparations, suitably adapted for: (a) implantation/ infusion into a human recipient or (b) extracorporeal treatment through bringing (non-human) animal cells into contact with human body fluids, tissues or organs
Drug Regulators, EMEA, Publish ICH Q4B Annex 12, Analytical Sieving General Chapter Guidance
Filed in manufacturing, December 30, 2009, 10:50 amThis annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Regulators, FDA, CDER, Publish Guidance on PET Drugs Current Good Manufacturing Practice (CGMP)
Filed in manufacturing, , 10:28 amThis guidance is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations
Drug Regulators, EMEA, Publish Guidance of the Development Of Medicinal Products for The Treatment of Cystic Fibrosis
Filed in clinical, , 8:47 amThe aim of this guideline is to provide guidance on the clinical development of compounds for the treatment of cystic fibrosis, a systemic chronically debilitating disease, mainly paediatric up to now, with a regularly increasing adult population as life expectancy improves (47% adults in 2006 according to ECFS, mean-aged 16-22 yrs).
Drug Regulators, EMEA, Publishes ICH Q4B Annex 11, Capillary Electrophoresis General Chapter Guidance
Filed in manufacturing, December 29, 2009, 10:47 amThis annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
Filed in labeling, licensing, , 10:24 amThis guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling.
Drug Regulators, FDA, Publish Guidance for Industry on Residual Solvents in Drug Products Marketed in the USA
Filed in manufacturing, , 8:44 amThis guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement2 for the control of residual solvents in drug products marketed in the United States
Drug Regulators, EMEA, Publish ICH,Q8,Q9 & Q10, Note for Guidance on Pharmaceutical Development, Quality Risk Management and Quality Systems Q&A
Filed in manufacturing, December 28, 2009, 10:33 amThis Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering Committee.
