Biological Regulators Provide Guidance on Submission of Lot Release Protocols
Filed in manufacturing, regulatory, September 30, 2009, 10:27 amThe Center for Biologics Evaluation and Research (CBER), are issuing this guidance under 21 CFR 601.14(a) to assist you, manufacturers of biological products regulated by CBER, in submitting lot release protocols in electronic format to CBER’s Product Release Branch
Drug Regulators Publish Q4B Annex9 & 10
Filed in Uncategorized, , 10:19 amThis annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Regulators Publish Concept Paper on CJD in Plasma-Derived and Urine-Derived Medical Products
Filed in EMEA, formulation, manufacturing, , 10:11 amThe document is the current EMEA/CHMP guidance on CJD and vCJD and plasma-derived and urine-derived medicinal products. It includes recommendations for these products based on the knowledge on CJD andvCJD epidemiology, human tissue distribution of infectivity/abnormal prion protein and infectivity in blood
US Senate Votes to Improve Drug Trial Access
Filed in business, clinical, , 9:48 amFour members of the US senate have introduced legislation to improve access to clinical trials for patients with rare diseases.
Drug Regulators Publish Concept Paper on Clinical Investigation of Specific Immunoglobulins
Filed in EMEA, clinical, regulatory, September 29, 2009, 3:01 pmno guideline on the clinical investigation of these human specific immunoglobulins is currently available. As the regulatory experience from the marketing authorisation applications, especially for human plasma-derived hepatitis Bimmunoglobulin has been developing during the past decades, the development of a guideline appears appropriate
Drug Regulators Publish Guidance on Clinical Evaluation of Diagnostic Agents
Filed in clinical, regulatory, , 2:57 pmThe revision of the points to consider on diagnostic agents was decided in order to reflect better the necessary steps in development of diagnostic agents as well as to define the assessment of benefits (technical performance, diagnostic performance, impact on diagnostic thinking and impact on patient management/outcome) and the risks related to the development of these agents
Drug Regulators Publish Draft Guidance on Clinical Investigations for Factor IX Products
Filed in clinical, regulatory, , 2:50 pmThis guideline describes the information to be documented when an application for a marketing authorisation for recombinant or plasma-derived factor IX products is made for use in treatment and prevention of bleeding in patients with haemophilia B.
Drug Regulators Publish Draft Guidance on Clinical Investigations for Factor VIII Products
Filed in clinical, regulatory, , 2:47 pmThis guideline describes the information to be documented when an application for a marketing authorisation for recombinant or plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A.
Regulators Publish Q&A’s on EWP therapeutic subgroups on Pharmacokinetics
Filed in clinical, regulatory, , 2:43 pmThe objective is to address specific questions in relation to pharmacokinetic evaluations and particularly the requirements and assessment of bioequivalence studies
Drug Regulators Publish Concept Paper Requiremtns for Guidance on the Clinical Investigation of Products for Lipid Disorders and Hypertension
Filed in clinical, regulatory, September 28, 2009, 9:25 amCurrent CHMP recommendations for the clinical development of lipid lowering and blood pressure (BP) lowering agents accept the possibility of drug registration for the so called biological indications. This means that the basis for the demonstration of the efficacy of these drugs can be their effect on biological markers (LDL-cholesterol and BP respectively)
