Drug Regulators – Traditional Herbal Medicines Advertising Guidance
Filed in marketing, regulatory, July 31, 2009, 8:13 amThe guidance is intended for advertisers of traditional herbal medicinal products (THMs) holding a registration certificate granted by the MHRA under the Traditional Herbal Medicines Registration Scheme.
Drug Regulations, EMEA publishes ICH E16 – Genomic Biomarkers for Drug Responses
Filed in clinical, pre-clinical, regulatory, July 30, 2009, 9:54 amThe EMEA has published “ICH Topic E16 Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions”
ICH M3 (R2) Non-clinical Safety Studies Guidance updated by EMEA
Filed in clinical, pre-clinical, regulatory, July 28, 2009, 10:16 amThe EMEA published new guidance on ICH Topic M 3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
Drug Development Regulations – EMEA releases draft guidline on Epidemiology Data on Blood Transmissible Infections
Filed in clinical, manufacturing, regulatory, July 27, 2009, 7:36 amIn the light of experience gained with the application of the Guideline on Epidemiological data (published in Jan. 2005) a group of experts was assigned to critically look at the: 2006 epidemiological data submitted in the Plasma Master File (PMF) annual update, in conjunction with the CHMP Epidemiological guideline, 2006 and 2007 PMF evaluation reports for the relevant PMF Feedback on this work was provided to the PMF Drafting Group and to BWP/CHMP and a revision of the guideline was recommended.
Twitter Weekly Updates for 2009-07-26
Filed in Uncategorized, July 26, 2009, 3:20 pmdevelopment planning is not just about science, its about markets too! And making yourself attractive to specific investors! #
Respect the companies who pitch for your work! Writing propsals takes time! Reward the effort with writen feedback as a minimum! #
When working with clients on a project the requiements change, as a consultant you have to [...]
Drug/Biotech Development Fund, UK government announces GB£150m fund
Filed in Fund raising, business, July 24, 2009, 8:37 amThe Department for Business, Innovation and Skills, with the Department of Energy and Climate Change and the Department of Health, will invest £150 million alongside private sector investment on an equal basis known as pari-passu.
FDA introduces new Rules of IRB Registration
Filed in clinical, regulatory, July 23, 2009, 9:34 amThe FDA IRB Registration Rule is effective Tuesday, July 14, 2009. All IRBs reviewing FDA-regulated research must register between July 14 and September 14, 2009.
Drug Markets – USA Regulators Go After Deals That Slow Generic Competition
Filed in business, July 21, 2009, 9:25 amAccording to a brief filed with a federal appeals court in New York, the Department of Justice (DOJ) said that pharmaceutical patent settlements that delay the introduction of generic drugs to the market are “presumptively unlawful.”
NICE blueprint for fast track drugs in NICE bypass
Filed in marketing, July 20, 2009, 8:28 amThe UK government’s Office for Life Sciences (OLS) announced plans Tuesday to accelerate access to innovative drugs by proposing that certain treatments be allowed to bypass appraisal by the National Institute for Health and Clinical Excellence.
Development Funding – New £15million Venture Capital Fund in North West
Filed in Fund raising, business, , 7:52 amThe Northwest Regional Development Agency (NWDA), with support from the European Regional Development Fund (ERDF), has announced a £15m transitional venture capital (VC) & loan fund for businesses in the region, at the Business Finance 09 seminar in Manchester today (Monday 29th June).
