The addition of efficacy data from FDA/EMA drug approval
documents helps to improve clinical and translational study designs and facilitate development decisions
However, the drug should only be used in combination with on-going therapy, an unprecedented requirement for a drug approval
Among their topics are the approval process for new drugs before and after 1962, the generic drug approval
process after the 1984 Hatch-Waxman reform, the influence of the Prescription Drug User Fee Act on the approval process, active pharmaceutical ingredients, current good manufacturing practice and the drug approval
process, ways and means to registering foreign drugs in the US, and the impact of government regulations on marketing and advertising.
Regulatory requirements in the United States define a two-year post-approval retention period for all the documentation supporting the filing for a new drug approval
medical procedure campaigns, automotive safety policy, drug approval
, legal reform, business accounting and environmental issues.
How many more people have died or suffered waiting for drug approval
by the FDA than have been saved by its prevention of unsafe or ineffective drugs'?
But the industry argues that the current drug approval
process is more than adequate and the safety record of prescription drugs in the U.
The advisory committee had some concern that the FDA was not be able to review all the data on treatment-experienced patients before the legal deadline for drug approval
Accelerated drug approval
was one of most important accomplishments of early AIDS activism.
In addition, adding significant numbers of pediatric tests to the drug approval
regimen means that more children will be needed for those trials of untested drugs.
According to the Post: "'Faster drug approval
inevitably heightens risks,' said FDA Commissioner David A.
Although University of Chicago statistician Paul Meier voted to recommend approval, he cautioned that the panel might be "ratcheting down" the usual standards for drug approval
in order to speed a new AIDS treatment to market.