Jul 2011

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Jerusalem: The biotech capital. A number of major international biomedical companies are negotiating to open research and development centers in Jerusalem. Among the big names in contact with the Jerusalem Development Authority are Pfizer, Merck and Bristol-Myers Squibb.

The Israeli Ministry of Health Clinical Trials Department will hold training days about clinical trials regulatory requirements in Medical Devices & Advanced Therapies.

The Israeli Association for the advancement of the Biomedical Research Community has published the summary minutes of the steering committee meeting (Hebrew)

FDA issues a Draft Guidance for Medical Apps. With the explosion of apps that do everything from help people control their blood glucose levels to act like a stethoscope, the US FDA issued a draft guidance on how it will oversee such apps for smartphones or other mobile devices

The FDA has published a Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices.

The FDA has published a Final Rule: Medical Devices; Exception From General Requirements for Informed Consent

Despite seeing benefits, industry awaits FDA final guidelines before adopting adaptive design trials. The promise of adaptive design clinical trials exists, with increased ethical treatment of patients, greater likelihood of finding the optimal dose and shortened study duration. But a variety of sponsor and CRO barriers—lack of experienced personnel with the required skills and knowledge, misunderstood benefits and greater complexity of design and trial implementation—have slowed their widespread adoption.

Survey: clinical trial costs rapidly increasing. Increasing competition for trial sites and CROs that can yield reliable, high-quality data is raising the costs of clinical trials, according to a recent survey from Cutting Edge Information.