Is the FDA Approving Drugs Too Quickly?

The FDA has been accused of delaying drug approvals: now it is accused of acting too hastily in approving drugs that have later had to be withdrawn.

FDA Drug Approvals Are Faster But Rely On Less Evidence ... - NPR

FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find · Shots - Health News · One-Third Of New Drugs Had Safety ...

How Do Drugs Get Approved (and Fast-Tracked) by the FDA?

Every prescribed drug in the U.S. has gone through a rigorous testing process that can take over a decade to complete before the U.S. Food and ...

FDA approving drugs after fewer trials, providing less information to ...

CORVALLIS, Ore. — The U.S. Food and Drug Administration is approving more novel pharmaceutical drugs based on single clinical trials and ...

The hazards of rapid approval of new drugs - PMC

The approval of new drugs is a complicated and sometimes controversial process. Even the US Food and Drug Administration (FDA), one of the largest regulatory ...

Speedier drug approvals hit slowdown as FDA faces scrutiny

In less than two years, the FDA has successfully called on drugmakers to remove more than 20 approvals from accelerated drugs — mainly cancer ...

Is the FDA Approving Drugs Too Quickly? - BioSpace

The European Medicines Agency (EMA) also has formal policies based on limiting the number of days a drug is being reviewed—210 days for regular ...

FDA increasingly approves drugs without conclusive proof they work

As pharma companies underwrite three-fourths of the FDA's budget for scientific reviews, the agency is increasingly fast-tracking expensive ...

5 things to know about the FDA's flawed approach to accelerated ...

... FDA's accelerated approval of drugs for urgent medical needs ... "We were approving them so fast that there was no literature for ...

Is the FDA approving drugs too fast? - ProQuest

Through much of the past decade the FDA has been accused of delaying drug approvals: now it is accused of acting too hastily in approving drugs that have later ...

FDA fast-tracking approval of new drugs — fewer trials, less info

The Food and Drug Administration is approving new drugs after ... The FDA is now fast-tracking new drug approvals — why that's so worrying.

FDA's Drug Review Process: Continued

Manufacturing issues are also among the reasons that approval may be delayed or denied. Drugs must be manufactured in accordance with standards ...

FDA Is Not the Problem - Center for American Progress

Today, the FDA approves the overwhelming majority of new drugs, and does so at a quicker pace than any other nation. Furthermore, federal law ...

The FDA approves many drugs that haven't been shown to work

Last year, 14 new drugs received so-called accelerated approval, in which they have not gone through the testing that the Food and Drug ...

Trends in utilization of FDA expedited drug development ... - The BMJ

Conclusions In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or ...

Is the FDA Approving Drugs too Quickly? - Pharmacy Times

A recent study of trends in FDA drug approvals revealed an increase in the instance of expedition in regards to investigative drugs. This raises ...

Frequently Asked Questions about the FDA Drug Approval Process

Clinical trial results allow the FDA to make decisions about whether or not a drug should be approved for marketing. For more information, ...

5 things to know about the FDA approval process

Just because a drug or vaccine is developed quickly doesn't mean researchers are taking shortcuts. “The FDA vaccine development program is one ...

The FDA Is Approving Drugs Faster, But That May Not Be A Good ...

In a second research report published this year so far, investigators found that the U.S. Food and Drug Administration (FDA) is approving drugs ...

Too Fast or Too Slow? Debate Intensifies over FDA Regulatory ...

The surge in new drugs gaining FDA approval based on small, early clinical studies and fast-track reviews has raised concerns about patients ...