Posts Tagged ‘PDUFA’
America’s Healthcare Crisis–Part V–FDA Complicit in Crimes
FDA, a complicit partner in crimes and corrupt industry practices have resulted in an epidemic of preventable injuries and deaths.
Read MoreAmerica’s Healthcare Crisis–Part II–What Do We Get for $$$ ?
Part II. What Do We Get for All That Money? A preventable epidemic of injury and death from prescription drugs; FDA’s contribution to the epidemic; Big Pharma’s business model: manufactured myths, propaganda and a hidden agenda;
FDA: This Agency Can Be Dangerous_Marcia Angell
"… the basic missions of industry and regulators are different, and inherently somewhat adversarial, no matter how pleasant the relationship…"
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Avandia Face-Off_GSK–Dr. Steven Nissen
GSK Executives: "frankly, the last thing we want to do is get into a public debate about whose analysis is right."
Read MoreLetter of Complaint to FDA Commissioner, 2007
Complaint about a surge of FDA administrative approvals for expanded use of highly toxic antipsychotic drugs for children. Approvals were determined by Dr. Thomas Laughren after secret deliberations–without disclosure of scientific data, without an advisory panel or open public discussion.
Read MoreThe Damaging Impact of PDUFA and Why It Should be Repealed
The re-prioritization of rapid approvals occurred at the expense of drug safety standards,
Read More“Big Bucks, Big Pharma” Video documentary
See: http://ahrp.blogspot.com/2007/01/big-bucks-big-pharma-documentary-video.html And see, PDUFA-Payola see: http://pharmamkting.blogspot.com/
Read MoreNass – Senate Subcommittee on Bioterrorism & Public Health Preparedness – Biodefense
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 for the record. My name…
Read MoreAnother deadly drug recalled – FDA asks Congress for Power to Dictate Warnings
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 drug effects. The Associated Press…
Read MoreNass – Senate Subcommittee on Bioterrorism & Public Health Preparedness – Biodefense
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 for the record. My name…
Read MoreThe Impact of the FDA Modernization Act on the Recruitment of Children for Research
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 shift in public policy since…
Read MorePBS: “Bitter Pill” Based on Bloomberg Pharma’s Shameful Secret Report Airs on Friday 9/8
AIR: America’s Investigative Reports, is a new Public Broadcasting System (PBS) series whose first report, "A Bitter Pill," airs Friday, Sept. 8.
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