Sentence examples for drug review process from inspiring English sources

But proposals to use biomarkers have created a deadlock in the drug review process: FDA reviewers aren't confident that the biomarkers submitted in new drug applications are reliable, committee staff members say, while drug sponsors are uncertain that these tools will help them win approval.

Pharmaceuticals, meanwhile, want to see specific modernizations made to the drug review process.

The HHS and FDA drug review process is supposed to determine whether drugs are safe and effective.

Age and parental-notification restrictions on abortions are supposed to be handled at the state level, not through the HHS drug review process.

This ultimately provided impetus for the passage of legislation sharply tightening the previously lackadaisical drug review process.

The user fee program has been a great success over the last two decades, as the increased funding from pharmaceutical companies has enabled the FDA to add about 200 staff members and lessen the drug review process almost in half.

The FDA could fast track drug review processes for those drugs that provide competition, say another anti-hepatitis C drug, or for ones in which the manufacturer promises to keep the prices below an affordability threshold that could be set by cost-effectiveness.

Changes in drug review processes may partially account for the peak in new drugs launched in the mid-1990s, and the generally higher levels observed in the latter half of the timeline.

But Friday's statement is the first detailed indication of how the FDA might use its drug-review process to tackle the problem.

Health Canada launched a Patient Involvement Pilot Project in 2014 to simulate how input from patients, their caregivers, health care professionals, and patient groups could be collected and incorporated in the drug submission review process.

The number of drugs assigned a priority review by Health Canada may be due to pressure from the pharmaceutical industry, since user fees from the industry account for about 50% of the operating budget for the drug submission review process.