Category Archive
The following is a list of all entries from the formulation category.
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Drug Regulators Publish Draft Guidance on Helicobacter pylori associated Duodenal Ulcer Treatments
Filed in clinical, formulation, manufacturing, pre-clinical, regulatory, November 5, 2009, 9:12 pmThe purpose of this guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by Helicobacter pylori (H. pylori) for the reduction of duodenal ulcer recurrence. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs to support antimicrobial-containing H. pylori treatment regimens
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
FDA Publishes New Guidance Page – Memoranda to Blood Establishments
Filed in biotechnology, clinical, formulation, labeling, manufacturing, pre-clinical, regulatory, October 31, 2009, 12:10 pmBlood memoranda have not been issued since January 1997. This information is now being issued as guidance documents.
Drug Regulators Publish Concept Paper on CJD in Plasma-Derived and Urine-Derived Medical Products
Filed in EMEA, formulation, manufacturing, September 30, 2009, 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
Drug Regulatos, FDA, Reppost Guidance on CMC Submissions for Therapeutic Recombinant DNA-Derived Products or Monolconal Antibody Products
Filed in formulation, manufacturing, regulatory, September 14, 2009, 9:08 amThe FDA has re-posted guidance first published in 1996 “FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE”
This guidance provides a section by section description of the Chemistry, manufacturing and control section of an FDA submission, its aimed specifically at Specific Biotech products, but should be considered by other related technologies. There is no apparent reason for the re-posting but it could be the FDA is planning an update.
Drug Regulators Publish Concept Paper on CJD and Plasma-Derived Medicinal Products
Filed in formulation, manufacturing, regulatory, September 8, 2009, 10:22 amThe proposed document will replace the CHMP Position statement on Creutzfeld-Jakob Disease and plasma-derived and Urine Derived Medical Products (EMEA/CPMP/BWP/2879/02 Rev 1) These guidlines need to be updated beacuse there have been 4 cases of vCJD infection associated with blood transfussion of non-leucodepleted red blood cells. TSE infectivity has also been detected in urine in some animal models.
Drug Regulators EMEA Publish Concept Paper on the Need to Revise the Guidlines on the use of Transgenic Animals in Biological Manufacture.
Filed in biotechnology, formulation, manufacturing, August 18, 2009, 10:58 amThe EMEA has published the following “CONCEPT PAPER ON THE NEED TO REVISE THE GUIDELINE ON THE USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE (3AB7A OF JULY 1995)”
Drug Development Regulations – Q4B Annex
Filed in formulation, regulatory, July 16, 2009, 9:38 amEMEA publishes ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TABLET FRIABILITY GENERAL CHAPTER(EMEA/CHMP/ICH/379801/2009)
Rapid Drug Discovery and Development Facilitated by ICH
Filed in clinical, formulation, manufacturing, pre-clinical, regulatory, July 8, 2009, 9:07 amThe International Conference on Harmonisation of Technical Requiremtns for REgistration of Pharmacetucials for Human use, steering committee and expert working groups met in Yokohama in June (6th to 11th) and a number of highlights are outlined below
