Drug Lag

A pharmaceutical industry term for the delay before a new agent is allowed into the US drug marketplace
References in periodicals archive ?
To make contributions to resolving the drug lag in Japan by developing drug products for which affiliated academic societies and other organizations deem there is a significant need.
He points out that the Prescription Drug User Fee Act (PDUFA), by charging drug companies large fees to have their drugs considered by the FDA, has reduced the drug lag.
22) Part of Young's approach was the promulgation of a number of new regulatory measures to deal not only with the AIDS epidemic but also the drug lag.
He vowed to speed up the drug approval of totally new drugs, mitigate the drug lag, and "foster a more cooperative spirit" with the pharmaceutical industry through the promotion of "voluntary action.
Sponsors "couldn't figure out our regulations, so that caused a drug lag in the 1980's.
Deaths due to the drug lag have been numbered in the hundreds of thousands.
The Drug Lag Each new drug to be introduced onto the Canadian market has to receive HPB approval.
The regulatory regime has many unique features including the drug lag, the 90% rule, a divergent biosimilar approval pathway, biennial price cuts, Iyaku Bungyo and requiring local clinical trials for approval.
Japan aims to reduce its drug lag by bringing the median total time for standard reviews for new drugs down to 12 months during the fiscal year to March 2012.
Studies of the FDA showed that the increase in cost and time to market resulted in substantial drug lag and drug loss.
Understand the use of biomarkers and surrogate endpoints, improvised clinical trial designs and better recruitment and retention of subjects in clinical trials, in order to avoid drug lags in various phases of development.