Report calls for major changes in drug-approval process, but will they be implemented?

A Robinson - CMAJ: Canadian Medical Association Journal, 1993 - ncbi.nlm.nih.gov
A new drug-review system that gives Canada's physicians important new re-sponsibilities is
taxiing toward the runway, butits cardinal element may not be on board. Plansfor the new …

New submissions adding to federal government's drug-approval backlog.

J Rafuse - CMAJ: Canadian Medical Association Journal, 1991 - ncbi.nlm.nih.gov
T he goals were lofty, the task formidable. In 1988, reacting to concerns raised by drug
makers, the auditor gener-al and three federally sponsored studies, the Department of Na …

Reviewing new drugs: does Ottawa finally have the right prescription?

A Gilmore - CMAJ: Canadian Medical Association Journal, 1988 - ncbi.nlm.nih.gov
N omatter how much you try to ignore them, some problems simply don't go away. Take, for
example, those affecting Canada's system for approving prescription drugs. It has been clear …

[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 …

A national drug agency

R West, EK Borden, JP Collet, NSB Rawson, RS Tonks - CMAJ, 2003 - Can Med Assoc
Like the editors of CMAJ, 1 we strongly support the Romanow Commission's
recommendation for a national drug agency. 2 Our recent study 3 showed that the current …

More staff, faster approvals?

C Thatcher - Canadian Pharmacists Journal, 2002 - search.proquest.com
In a paper published in the summer edition of The Canadian Journal of Clinical
Pharmacology, he compared drug approval personnel in the US, UK, Sweden, Australia and …

Drug review, approval process changing

MF Goldsmith - JAMA, 1985 - jamanetwork.com
The FDA made news this year when it put into effect substantial revisions of the regulations
that govern the drug review and approval process. The revisions have altered the way drug …

Drug Evaluation by Council on Drugs

JR Lewis - JAMA, 1963 - jamanetwork.com
WHEN A PHYSICIAN writes a prescription for a completely new drug, it is a moment of great
decision. He has had to assess a welter of claims before deciding to use a new drug in …

The drug regulation reform act of 1978

AJ Ryan - Postgraduate Medicine, 1978 - Taylor & Francis
Allan J. Ryan, MD recently issued a memorandum based partly on the recommendations of
the DHEW review panel on new drug regulation. lt is in the form of a draft ofproposals for …

Drug legislation in the silly season.

AJ Kirshen - CMAJ: Canadian Medical Association Journal, 1987 - ncbi.nlm.nih.gov
Dr. Goldman and others have drawn attention to current data indicating that propylthiouracil
can be safely used by nursing mothers. Although those data suggest that this drug is not con …