PDUFA


Submitted Testimony of Meryl Nass, MD Mount Desert Island Hospital Bar Harbor, Maine 04609 (207) 288-5082 ext. 220 Senate Subcommittee on Bioterrorism and Public Health Preparedness Hearing: Biodefense: Next Steps Tuesday, February 8, 2005, 10 am SD-430 Dirksen Senate Office Building Thank you for the opportunity to submit this testimony […]

Nass – Senate Subcommittee on Bioterrorism & Public Health Preparedness ...


THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the […]

The Impact of the FDA Modernization Act on the Recruitment ...


Another deadly drug recalled – FDA asks Congress for Power to Dictate Warnings Tue, 1 Mar 2005 Public pressure has intensified as FDA’s failure to protect the public from unsafe – even lethal drugs. That failure included the failure to at least warn physicians and the public about severe adverse […]

Another deadly drug recalled – FDA asks Congress for Power ...





“More than a year after the Food and Drug Administration announced it had strengthened its drug safety system, the agency still lacks a reliable system for keeping track of emerging problems, congressional investigators concluded in a report to be released today.” [Los Angeles Times, below]

GAO Report Gives FDA Flunking Grade in Detecting Drug Dangers







Thank you for the opportunity to submit this testimony for the record.

My name is Meryl Nass, M.D., and I have worked for the past twenty years as an emergency physician and internist in community hospitals in the northeastern US. I have also studied many aspects of bioterrorism since 1989. I am the person who first demonstrated, in 1992, that one could investigate an epidemic retrospectively, and prove that it was due to biological warfare, using Rhodesia's 1978-80 anthrax epidemic as a model.[1]

Testimony of Meryl Nass, MD – Senate HELP Committee, Subcommittee ...