Tag: FDA
FDA Defends Decision to Approve Digital Aripiprazole
Members of the U.S. Food and Drug Administration’s Psychiatry Products division go on the defensive in a new article, responding to concerns about the agency’s approval of digital aripiprazole.
FDA Shakes Up Guidance on Antidepressant Trial Design
From MedPage Today: "The FDA released new draft guidance for development and testing new pharmacologic agents indicated to treat major depressive disorder (MDD).
For example, the new guidance...
We Pay a High Price for Unregulated Medical Devices
From The Lown Institute: New investigations and research are beginning to show the dangerous consequences resulting from the FDA's lack of oversight of medical devices.
"It sounds crazy...
It’s Time to Levy Penalties for Failing to Report Clinical Trial...
From STAT: A decade after the Food and Drug Administration Amendments Act went into effect, requiring the results of clinical trials to be reported on the government website ClinicalTrials.gov, the government has never levied a single monetary penalty or withheld research funding under the law.
Think You’re Seeing More Drug Ads on TV? You Are.
From The New York Times: TV drug ads have dramatically increased in the past few years. According to Kantar Media, a firm that tracks multimedia advertising,...
Is the FDA Withholding Data to Protect a Drug Manufacturer?
From Scientific American: The FDA seems determined to prevent the public from accessing valuable data about the safety, efficacy, and potential adverse effects of the...
More Follow Up Needed for Drugs Granted Accelerated FDA Approval
Drugs to treat serious or life-threatening conditions can receive accelerated FDA approval, but may expose patients to increased safety risks and reduced efficacy.
Has the Era of Gene Therapy Finally Arrived?
From Scientific American: The FDA has announced its approval of Kymriah, the first gene therapy in the U.S. However, gene therapy remains far from fulfilling...
FDA Seeks Input on Drug Risk Information in Broadcast Ads
From FDA in Brief: The FDA seeks input from consumers and medical professionals on making sure the drug risk information in statements included in direct-to-consumer...
Prescription for Murder ABCD
The Anything But the Company Drug playbook involved digging deep into the medical records of the person reporting a problem in order to find the ingrown toenail at the age of two that was possibly the cause. And of course if something else was possibly the cause, then we can’t conclude that our drug did it.
Jim Gottstein: Patient Rights in Mental Healthcare
Jim Gottstein, president and founder of the organisation Law Project for Psychiatric Rights, talks about his own experiences with the psychiatric system, patient rights in mental healthcare and the recent trial between Wendy Dolin and the UK Pharmaceutical manufacturer GlaxoSmithKline.
Scott Gottlieb Confirmed as Head of the FDA
From Pacific Standard: This past Tuesday, the Senate confirmed Scott Gottlieb as head of the Food and Drug Administration.
"Although some Senate Democrats had worried about...
Change in Chicago: Playing Go
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.
Dear Scott Gottlieb: Add New Warnings to Paxil Labels
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...
Trump’s Pick to Oversee Big Pharma has Ties to Opioid Industry
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...
Researchers Make Recommendations to Improve FDA Transparency
Organizations, advocates, scholars, and practitioners had a chance to give feedback regarding FDA processes.
Show Drugs Work Before Selling Them
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...
Trump Chooses Gottlieb to run FDA; Big Pharma Relieved
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...
FDA Approved Drugs may Become Riskier
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...
How big Pharma’s Lust for Profit Harms Their Customers
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...
I do Hate to Tell you This, but…
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...
Cancer Drug Offers a Cautionary Tale of Deregulating the FDA
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...
Trump Wants to Blow up the FDA
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...
“Trump is Considering a Radical to Lead FDA. That’s Dangerous for...
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...
“House Passes Controversial Medical Funding ‘Cures’ Bill”
“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...
