Is the FDA approving drugs too fast?

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of delaying drug approvals: now it is accused of acting too hastily in approving drugs that have later had to be withdrawn.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

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

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 ...

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 ...

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 ...

Accelerated Approval | FDA

Using a surrogate endpoint enabled the FDA to approve these drugs faster. ... In 2012, Congress passed the Food and Drug Administration Safety ...

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 ...

FDA increasingly approves drugs without conclusive proof they work

Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency. Europe ...

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 ...

Bashing accelerated approval isn't supported by the data - STAT News

A crucial lesson learned from the FDA's Patient-Focused Drug Development initiative is that patients are often willing to accept heightened risk ...

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority ...

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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 ...

FDA Is Not the Problem - Center for American Progress

Why Undermining the Drug Approval Process Is Not the Answer to High Drug Prices ... Cutting corners by pushing the FDA to approve more drugs on ...

FDA is approving drugs faster than ever—but is this a good thing?

FDA's drug approval process has accelerated over the last four decades, but a study published Tuesday in JAMA indicates the evidence behind ...

Speed Up Drug Approvals? FDA Already Did - NBC News

President Donald Trump said he wants the FDA to approve drugs even faster, with fewer regulations. But no one really wants that to happen.

Accelerated Approval Program - FDA

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug ...

Accelerated Approval for New Drugs: Controversies, Proposed Fixes

Established in 1992 in response to the HIV/AIDS crisis, the accelerated approval pathway allows the FDA to speed approval of drugs based on a “ ...

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 ...

Is the FDA Approving Drugs too Quickly? - Pharmacy Times

The study, carried out by The BMJ, describes how the FDA is increasingly expediting development and approval of drugs that are deemed to be ...