drug approval

The formal process through which drugs are tested before they are permitted to be sold. In the U.S., the process involves a series of studies on small groups of patients affected by diseases for which the drug may prove beneficial. These trials include: 1. studies of the drug's safety; 2. studies of the drug's efficacy; 3. studies of the drug's comparative efficacy relative to other agents that treat the same or similar problems.

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The addition of efficacy data from FDA/EMA drug approval documents helps to improve clinical and translational study designs and facilitate development decisions

Elsevier Delivers Data Insights to Help Improve Phase I and Phase II Clinical Trials with the Launch of PharmaPendium Efficacy Module

However, the drug should only be used in combination with on-going therapy, an unprecedented requirement for a drug approval.

Prozac & therapy OK for Europe kids

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.

The Pharmaceutical Regulatory Process

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 (NDA).

Digital archiving in the pharmaceutical industry: while relatively new as a retention method in the drug industry, e-archiving of records is a must-do to best ensure the health of patients and the industry

medical procedure campaigns, automotive safety policy, drug approval, legal reform, business accounting and environmental issues.

PJB Publications launches "Healthcare Lobbyist"

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'?

Hazards of the FDA

But the industry argues that the current drug approval process is more than adequate and the safety record of prescription drugs in the U.

A spoon full of sugar: what drug companies don't want you to know

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.

New protease inhibitor atazanavir (Reyataz[TM]) approved

Accelerated drug approval was one of most important accomplishments of early AIDS activism.

Accelerated approval: where are we now? (Viewpoint)

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.

FDA/HHS keep Pediatric Rule in effect -- CA, other groups continue suit

According to the Post: "'Faster drug approval inevitably heightens risks,' said FDA Commissioner David A.

Risky behavior

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.