Tag Archive
The following is a list of all entries tagged with clinical:
Drug Regulators, FDA, Publish Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologicals.
Filed in clinical, March 4, 2010, 11:22 amThis guidance provides sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with information regarding adaptive design clinical trials when used in drug development programs.
Drug Regulators, EMEA, Publish an Overview of Comments Received on Draft Guidance on Clinical Investigations of Medicinal Products Used in Osteoarthritis
Filed in clinical, February 15, 2010, 11:58 amInterested party (Organisations or individuals) that commented on the draft Guideline as released for
consultation
Stakeholder
No.
Name of Organisation or individual
1 OARSI, Osteoarthritis Research Society International
2 USZ, Department of Rheumatology and Institute of Physical Medicine, University Hospital
of Zurich, Switzerland
3 AESGP, Association of the European Self-Medication Industry
4 EFPIA
5 GREES, Osteoarthritis section
6 EULAR
Drug Regulators, EMEA, Release Overview of Comments Received on Draft Guidance on Clinical Evaluation of Diagnostic Agents
Filed in clinical, February 5, 2010, 4:48 pmComments contributed by:
Drug Regulators, European Medicines Agency, Publish Concept Paper on Revision of the Notes for Guidance on Gene Transfer Medicinal Products
Filed in biotechnology, clinical, formulation, manufacturing, pre-clinical, January 19, 2010, 9:46 amThis Concept Paper proposes a revision of the Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (CPMP/BWP/3088/99) that came into effect in 2001.
Drug Regulators, EMEA, Publish Guidline on Xenogenic Cell-Based Medicinal Products
Filed in clinical, manufacturing, December 31, 2009, 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, Re-Publish Guidance on Special Populations Geriatrics
Filed in EMEA, clinical, regulatory, November 20, 2009, 12:16 pmThis guideline is directed principally toward new Molecular Entities that are likely to have significant use in the elderly, either because the disease intended to be treated is characteristically a disease of aging ( e.g., Alzheimer’s disease) or because the population to be treated is known to include substantial numbers of geriatric patients (e.g., hypertension)
Drug Regulatos Publish Draft Reflection Paper on In-vitro Cultured Chondrocyte Containing Products for Cartilage Repair
Filed in formulation, manufacturing, regulatory, November 3, 2009, 5:41 pmThis reflection paper addresses specific points related to products containing autologous chondrocytes intended for the repair of lesion of cartilage of the knee not discussed in the ‘Guideline on human cell based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline
Drug Regulators Publish ICH consideration on Virus and Vector Shredding
Filed in biotechnology, clinical, pre-clinical, regulatory, August 21, 2009, 8:02 amFor the purpose of this ICH Considerations document, shedding is defined as the issemination of the virus / vector through secretions and/or excreta of the patient.
Drug Regulators Publish Reflection Paper – Development of Similar Interferon Alfa
Filed in clinical, pre-clinical, regulatory, July 17, 2009, 9:28 amThe EMEA, published a reflection paper on the Non-Clinical and Clinical Development of Similar MEdicinical Products Containing Recombinant Interferon Alfa. in 2007, and has re-published the document on their website again.
Drug Development Regulations and Guidance from EMEA – Clinical Evaluation of Antifugals
Filed in clinical, regulatory, July 2, 2009, 10:45 amDrug development regulations and guidance from the EMEA has been published in draft for comment on Clinical Evaluation of Antifungals
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