Tag: FDA

The jury was out for days. And when they came back it became clear they were wrestling with the issue of who to blame. This was like playing Go, where it can look like the black counters on the board have white encircled until white puts down one more piece and all of a sudden it wins.

From STAT: Scott Gottlieb, Trump's pick to lead the FDA, should consider pursuing a stronger warning label for the antidepressant Paxil. Paxil's label currently does...

From The Intercept: Newly released documents show that Dr. Scott Gottlieb, President Trump's nominee to lead the FDA, has received almost $45,000 in speaking fees...

Organizations, advocates, scholars, and practitioners had a chance to give feedback regarding FDA processes.

From Nature: FDA regulation plays a major role in the functioning of our economy. Trump's plans to deregulate the FDA will not only put...

From Reuters: President Trump has selected Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the FDA. Article...

From the Center for Health Journalism: President Trump's plans to speed up the process of FDA drug approvals, in combination with the increase of off-label...

From AlterNet: The increasing pace at which the FDA is approving new drugs can lead to significant risks to patient safety. Drugs that once would have...

In this commentary for In the Pipeline, Derek Lowe highlights the results from a recent FDA report showing that the vast majority of all drugs...

To illustrate the dangers of Trump's plans to deregulate the FDA, Susan Perry from MinnPost provides a cautionary tale about Tarceva, a drug approved by the...

From STAT: President Trump plans to decrease regulations on the Food and Drug Administration. Medical experts and healthcare professionals have expressed concerns that this could expose...

For STAT, Ed Silverman writes, “the incoming Trump administration may seek to undo a decades-old standard of evaluating drugs for effectiveness — to the detriment of...

“Democrats and consumer groups were upset with the bill's streamlining of some Food and Drug Administration processes, including making it easier for companies to...

Instead of reducing risk, the dose reduction recommendation made by the FDA in their safety message was associated with an increase in hospitalizations.

Kaiser Health News and NPR report on the immense lobbying effort aimed at passing the "21st Century Cures" Act which would fast-track FDA approval...

Several members of Congress spoke this weekend signaling that they were ready to vote on legislation designed to speed federal approval of new drugs...

For STAT, Ed Silverman reports that Gordon Johnston, a former FDA official, has agreed to a settlement after being accused of insider trading. “Johnston,...

Although the drug industry, our drug regulators and leading psychiatrists have done what they could to obscure these facts, it can no longer be doubted that antidepressants are dangerous and can cause suicide and homicide at any age.

From STAT: It “looks like the FDA is using this guidance to keep another company from trying to get a female sexual desire drug approved...

TIME magazine covers a new report suggesting that many medical reviewers who work for the FDA go on to work for the drug companies they...

Last week STAT hosted a panel of experts, asking “Is the Food and Drug Administration’s approval process broken?” Article →­

Sheila Kaplan reports for STAT on a new study finding that more than half of FDA drug reviewers went on to work for the...

STAT reports that the latest drug approval by the FDA “may have set a precedent that could rocket through the health care system, opening the...

This week an FDA advisory panel decided to remove warnings of serious psychiatric side effects from the Chantix product label. “In making its recommendation,...

Ed Silverman at STAT reports that Congress has linked increased research funding to “fast-track” approval procedures. “By linking the extra funds to speedier approvals,...