[HTML][HTML] Drug approval system questioned in US and Canada
L Eggertson - CMAJ, 2005 - Can Med Assoc
“There are serious problems in both the review function… and also in the postmarket
surveillance process.” Subsequent to Graham's testimony, a survey of almost 400 FDA …
surveillance process.” Subsequent to Graham's testimony, a survey of almost 400 FDA …
Drug approvals taking too long?
W Kondro - 2002 - Can Med Assoc
Health Canada, which takes an average of 2 years to review a licence application for a new
drug, has “one of the worse performances in new medication approvals in developed …
drug, has “one of the worse performances in new medication approvals in developed …
Paying for drug approvals—who's using whom?
J Avorn - New England Journal of Medicine, 2007 - Mass Medical Soc
Since 1992, the United States has relied heavily on the pharmaceutical industry to pay the
salaries of FDA scientists who review new drug applications. Dr. Jerry Avorn writes that most …
salaries of FDA scientists who review new drug applications. Dr. Jerry Avorn writes that most …
[HTML][HTML] New directions in drug approval
J Lexchin - CMAJ, 2004 - Can Med Assoc
Carole Lalonde user charges paid for close to 50% of the overall cost of running the drug
regulatory system. 8 Bill C-212 was introduced as a private member's bill by Liberal Member …
regulatory system. 8 Bill C-212 was introduced as a private member's bill by Liberal Member …
The FDA's accelerated approval process: does the pharmaceutical industry have adequate incentives for self-regulation?
VI Orlando - American Journal of Law & Medicine, 1999 - cambridge.org
Prompted by criticisms of long delays in its drug approval processes, the Food and Drug
Administration (FDA or the Administration) took a number of measures in recent years to …
Administration (FDA or the Administration) took a number of measures in recent years to …
FDA and drug safety: new tuffs study challenges critics of the Prescription Drug User Fee Act.
R Lee - Journal of Law, Medicine & Ethics, 2006 - go.gale.com
In the wake of several highly publicized lawsuits over drugs recalled for safety--most notably,
Vioxx and Paxil--the Food and Drug Administration (FDA) and the pharmaceutical industry …
Vioxx and Paxil--the Food and Drug Administration (FDA) and the pharmaceutical industry …
Comparison of drug approvals in europe versus the United States: An analysis of discrepancies between drug products reviewed by EMA and FDA
RW Makuch, R Shi - Therapeutic Innovation & Regulatory …, 2014 - journals.sagepub.com
Background: Regulators from the US Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) do not always agree on interpretation of data for a …
European Medicines Agency (EMA) do not always agree on interpretation of data for a …
New'FDA delivers in 2003
E Schmidt, R Wong - Nat Rev Drug Discov, 2003 - nature.com
A major contributor to the poor performance of the biotechnology and pharmaceutical
sectors in 2002 was the US FDA, which held products to an absolute and unnecessarily high …
sectors in 2002 was the US FDA, which held products to an absolute and unnecessarily high …
Rethinking and restructuring the FDA drug approval process in light of the Vioxx recall
AJ Dohrman - J. Corp. L., 2005 - HeinOnline
On September 30, 2004, Merck & Co.(Merck) announced that it would immediately withdraw
its second most profitable drug, Vioxx, from worldwide markets. 1 The company's …
its second most profitable drug, Vioxx, from worldwide markets. 1 The company's …
The drug approval process and the information it provides
A Myers, SR Moore, AG Hartzema… - Drug Intelligence & …, 1987 - journals.sagepub.com
By law, the commissioner of the Food and Drug Administration (FDA) is responsible for
determining whether a new drug is safe and efficacious before it is approved for marketing in …
determining whether a new drug is safe and efficacious before it is approved for marketing in …
