EMEA re-posts Points to Consider on Missing Data
Filed in clinical, medical report, regulatory, May 29, 2009, 10:10 amThe EMEA has reposted points to consider a missing data, this points to consider was formally adopted in 2001, however the EMEA has chosen to repost this on the website
EMEA republish points to consider on clinical investigation of medicinal products used in the treatment of osteoarthritis
Filed in clinical, regulatory, May 28, 2009, 11:03 amThe EMEA has republished points to consider on the clinical investigation of medicinal products used in the treatment of osteoarthritis, this was originally published in July 1998 however the EMEA has recently reposted on their website.
EMEA re-post Draft Guidance on the Clinical Evaluation of Anti-virals intended for HepC
Filed in Uncategorized, clinical, regulatory, May 27, 2009, 2:44 pmThe EMEA has reposted draft guidance on the “Clinical Evaluation of Direct Acting Antivial Agents Intended for the Treatment of Chronic Hepatitis C”. the guidance was originaly posted in April 2008, but the EMEA has re-posted it
EU announces 246 million Euros of medical research funding and tells us what they are looking for in the next round
Filed in Fund raising, business, May 20, 2009, 11:46 amThe European Commission and the EFPIA announced on Monday that 15 research projects were selected to receive a total of 246 million Euros (US$333 million) in research funding made available through the Innovative Medicines Initiative (IMI)
A Thought Provoking Consideration of Surrogate Endpoints
Filed in clinical, regulatory, May 19, 2009, 2:38 pmSurrogate endpoints are an essential part of the drug development professionals arsnel, without them many products would be too expensive and too long to be economicaly viable,
FDA guidance – Submission of Bioequivalence data for ANDA’s
Filed in clinical, formulation, regulatory, May 18, 2009, 8:31 amThis guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) in complying with FDA’s new requirements for the submission of bioequivalence (BE) data.
EMEA puts out a new concept paper – developing a guidline for the use of Pharmcogenomic Methodologies in the Pharmacokinetic Evaluation of Medicinal Products
Filed in clinical, pre-clinical, regulatory, May 15, 2009, 10:24 amEMEA put out a concept paper on “The development of a guidline on the use of pharmacogenomic methodologies in the pharmacokinetic evaluation of medicinal products”
Functional Foods Overstep the Claims – are Cheerios a drug? the FDA think so
Filed in Uncategorized, clinical, regulatory, May 14, 2009, 9:16 amGeneral mills the manufacture of Cheerios has been issued with a a warning letter from the FDA for “serious violations” of the FDC act in the label and labeling of Cheerios cereal, there lies a lesson in this for other companies making functional food claims.
US governemet to spend US$1.1 billion on Evidence Based Medicine
Filed in Uncategorized, business, May 13, 2009, 2:12 pmThe US government has stirred up a hornets nest of debate with plans to spend US$1.1 billion on evidence based medicine studies, of comparative effectiveness research as they call it
Pause in Normal Service
Filed in Uncategorized, May 11, 2009, 4:04 pmThere will be a pause in updates to this site, lasting approximately a week, as we move from one hosting provider to another, demand has caused some issues with the site that we intend to overcome with a move to a new hosting provider. However we will return will a whole series of articles on [...]
