update
EMA Includes Broader Range of PSURs in Risk-Benefit Assessments
The EMA has changed how it monitors the risk-benefit profile of marketed drugs, adopting a single assessment that includes a broader range of API safety reports.
Archives for April 3, 2013
Further Hope for Oral Insulin as Israeli Delivery Tech Gets Patent
Jerusalem, Israel-based drugmaker Oramed Pharmaceuticals has been granted patent approval for its oral insulin technology by the Japanese Patent office.
FDA Draft Guidance Focuses on Glass Syringe Compatibility
New draft guidance on the manufacture of glass syringes has been released by the FDA in response to a number of connection problems.
User-Friendly Clinical Trial Website Aims to Ease Patient Search Process
US Researchers say a new site MyClinicalTrialLocator.com gives patients a simple way of finding clinical trials and may aid sponsor and CRO recruitment efforts.
RPS, Asklep Form JV to Push Further into Japanese Market
RPS (ReSearch Pharmaceutical Services Inc.) says its JV with Asklep will provide more options for big pharma and biologic companies looking to outsource Japanese or pan-Asian clinical trials.