FDA to seek public comment on interim rule for wartime waivers of informed consent, Pendergast testifies.
FDA RECEIVING "VERY FEW" REQUESTS FOR EMERGENCY RESEARCH INFORMED CONSENT WAIVERS, FDA Deputy Commissioner Mary Pendergast testified at a May 8 hearing of Rep. Shays' (R-Conn.) Government Reform/Human Resources Subcommittee. "FDA has tracked all INDs and [Investigational Device Exemptions] submitted under this rule...to ensure its adequacy for protecting research subjects and to ensure it is appropriately applied," Pendergast said. "To date, there have been very few submissions under this rule. We have received one IDE application and four IND applications under the emergency research rule."
You may also be interested in...
Animal efficacy studies could support approval of new products to reduce or prevent the toxicity of chemical, biological, radiological or nuclear substances when efficacy cannot ethically be tested in humans, FDA proposed in a recent Federal Register notice.
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