Category Archive
The following is a list of all entries from the clinical category.
Drug Regulators, EMA (EMEA),Publish Guidance on the Development of Medicinal Products for the Treatment of Alcohol Dependence
Filed in clinical, March 8, 2010, 9:01 amAlcohol dependence is in general accepted as a psychiatric disorder with harmful physical, mental and social consequences and a high probability of a chronic relapsing course. It is considered a major public health problem in most Western societies. The aim of this guideline is to provide guidance on clinical studies for drugs developed for the treatment of alcohol dependence.
Drug Regulators, FDA, Publish Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologicals.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Drug Regulators, FDA, Publish Draft Guidance for Industry, Non-Inferiority Clinical Trials
Filed in biotechnology, clinical, March 2, 2010, 11:10 amThis guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with our interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic.
Drug Regulators, EMEA (EMA), Publish Comments Draft Guidance on the Investigation of Bioequivalence
Filed in clinical, marketing, pre-clinical, March 1, 2010, 11:47 amOrganisations that commented on the draft Guideline as released for consultation
Drug Regulators, EMA (EMEA), Publish draft guidance on Clinical Investigations in the Treatment of Diabetes Mellitus
Filed in clinical, February 26, 2010, 11:33 amDiabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidney, eye, nerves, heart and blood vessels.
Drug Regulators, EMEA (EMA), Publish a Concept Paper on the Need For Guidance on Clinical Investigations of Medicinal Products in the Treatment of Diabetes Mellitus
Filed in clinical, February 25, 2010, 11:33 amThe current CHMP Note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus CPMP/EWP/1080/00 was adopted by the CHMP in November 2002. New aspects have emerged since then including:
Drug Regulators, EMEA, Publish Addendum to the Note for Guidance on Evaluation of Medicinal Products Indicated for the Treatment of Bacterial Infections
Filed in clinical, February 16, 2010, 12:01 pmThis addendum to the Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CHMP/EWP 558/95 Rev 1) has been produced in response to recent advances in the development of agents intended for the treatment of disease due to Mycobacterium tuberculosis.
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, Publish Concept Paper on Need to Revise Points to Consider on the Clinical Investigation of Medicinal Products Other than NSAIDs in Rheumatoid Arthritis
Filed in clinical, February 14, 2010, 11:53 amSince 2003 this guideline has presented guidance for the clinical development of slow-acting anti-rheumatic medicinal products aiming at symptom- and/or structure-modification (e.g. DMARDs, biologics) for the treatment of rheumatoid arthritis (RA). In the last years efforts have been made in that field with regard to the development of new products with an improved efficacy profile and novel insights have been gained with respect to the assessment of disease activity, joint damage and disability.
Report: Review FDA, M3(R2) Nonclinical Safety, Pharmaceuticals
Filed in clinical, pre-clinical, February 8, 2010, 11:33 pmFDA Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.
