ICH final geriatric guideline
FDA announces availability of the document in the Aug. 2 Federal Register. Prepared by the International Conference on Harmonization's Efficacy Expert Working Group on Technical Requirements for Registration of Pharmaceuticals for Human Use, the guideline does not differ materially from the draft published in April 1993. FDA is seeking comments on an ongoing basis and will amend the guideline as needed
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth