Category Archive
The following is a list of all entries from the licensing category.
Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs
Filed in clinical, licensing, marketing, February 7, 2010, 4:55 pmThis guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)).
Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
Filed in labeling, licensing, December 29, 2009, 10:24 amThis guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling.
Drug Regulators, EMEA, Publish ICH M2, Common Technical Document, Updated Q&A
Filed in business, licensing, regulatory, December 26, 2009, 11:04 amThis question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification. The questions answered here relate to common questions that relate to the eCTD in all three ICH regions.
Medical Device Classification not Centrally Stored
Filed in devices, licensing, December 11, 2009, 10:15 amAt present no single organisation holds details of all medical devices – there are plans for the creation of a European Database, however these are not yet in place.
Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications
Filed in licensing, manufacturing, marketing, November 16, 2009, 4:18 pmThe Center for Biologics Evaluation and Research (CBER), FDA, are recommending ways that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for specified indications.
Regulators Publish Draft Guidance for industry on Risk Evaluation and Mitigation Strategies (REMS)
Filed in licensing, regulatory, November 4, 2009, 5:46 pmThis guidance applies to certain drug and biological products submitted for approval or approved under sections 505(b) or 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA), or section 351 of the Public Health Service Act (PHS Act), that are required by FDA to have a REMS
Access to Finance – New Yorkshire Forward Initative
Filed in Fund raising, licensing, March 4, 2009, 4:42 pmJust a breif note on a new Yorkshire Forward initiative, Access to Finance for Healthcare.
It is a programme designed to assist healthcare technology companies prepare for and go out on fund raising programmes, right up to being introduced to investors.
The programme is being run by Grant Thornton in Leeds and is on the back of [...]
Drug R&D Licensing Economy was US$340bn in 2007
Filed in licensing, report, October 14, 2008, 2:16 pmMost drug discovery and development companies rely on licensing to fund their technology development programmes, either directly or as an exit for investors. We have complied a report that represents an attempt to put a figure on the amount of money that is circulating in the drug discovery and development economy. (full report available see [...]
