Category Archive
The following is a list of all entries from the manufacturing category.
Drug Regulators, FDA, Publish Guidance on Characterisation and Qualification of Cell Substances and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Diseases
Filed in biotechnology, manufacturing, March 9, 2010, 9:02 amThe, FDA, are providing manufacturers of viral vaccines, with guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use
Drug Regulators, FDA, Publish Guidance on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
Filed in manufacturing, March 3, 2010, 11:16 amThis guidance provides recommendations to applicants on information to include in support of parametric release for sterile products terminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report.
Drug Regulators, FDA, Publish Guidance For Industry on Content of a Compleate Submission for the Evaluation of Proprietary Names
Filed in manufacturing, marketing, February 17, 2010, 12:06 pmThis guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission2 (see sections II. Background and III. PDUFA IV Goal Dates)
Drug Regulators, EMA, Publish Reflection Paper on Ethanol Content in Herbal Medicinal Products and Tranditional Herbal Medicinal Products Used in Children
Filed in Herbal, manufacturing, February 9, 2010, 12:21 pmHerbal medicinal products may contain significant levels of ethanol arising from its use as an extraction solvent in liquid extracts and tinctures or when added as a diluent to liquid herbal preparations. The use of ethanol is necessary for extraction of some constituents that are important for efficacy. Ethanol is metabolically active, therefore formulations without ethanol or with the lowest achievable level should be selected to avoid systemic exposure when the target population is children.
Drug Regulators, FDA – CDER, Publish Guidance on Use of Mechanical Calibration of Dissolution Apparatus CGMP
Filed in manufacturing, February 6, 2010, 4:52 pmThis guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances.
Drug Regulators, FDA CDER, Publish Guidance to Pharmacies on Compounding Oral Suspension
Filed in manufacturing, marketing, January 24, 2010, 10:04 amThis guidance provides recommendations to pharmacies on the advance compounding of Tamilfu oral suspension to provide multiple prescriptions. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.
£70 million Boost for UK manufacturing (including Regenerative medicines)
Filed in business, manufacturing, January 22, 2010, 9:57 amThe first three state of the art manufacturing research centres funded under a new £70M Government investment will be based at Southampton, Loughborough and Brunel universities, to help UK businesses develop the technology products of the future and underpin manufacturing growth, Business Secretary Lord Mandelson announced today.
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 Regulatory Guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.
Filed in business, manufacturing, January 12, 2010, 9:08 amThis guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities
Drug Regulators, FDA, Publish Guidance on An Acceptable Circular of Information for the Use of Human Blood and Blood Components
Filed in labeling, manufacturing, January 9, 2010, 8:39 amThe Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations the instruction circular entitled “Circular of Information for the Use of Human Blood and Blood Components” (Circular) dated December 2009
