Posts Tagged 'FDA'

Recent FDA Warnings For 11 Anesthesia Drugs May Be “Disservice to the Population”

questions over fda advice on anesthetics in childrenSome doctors feel that new warnings now required by the FDA on 11 anesthetic and sedation drugs may cause parents and guardians to needlessly put off life-altering or even life-saving procedures for their children. The warnings detail how extended use of the drugs might lead to brain damage. They apply to children aged three and younger, as well as pregnant women in their third trimester. The FDA has ...

continue reading...

Tarceva Settlement Highlights Flaws in FDA Drug Approval Process

tarceva shows flaws in FDA approvalsIn June of 2016 Genentech, Inc issued a letter to doctors telling them to stop prescribing Tarceva, a lung cancer drug, to patients unless those patients presented with a specific gene mutation. A recent story in the Los Angeles Times details how the drug was showing only a 10 percent effectiveness rate in patients taking it, while simultaneously causing rashes all over those patient’s bodies.

Tarceva was designed to block ...

continue reading...

FDA Cautions Against Excessive Anesthesia for Young Children

fda warns on anesthetics in childrenThe FDA is now requiring 11 anesthetic and sedation drugs to carry additional warnings on their labels because their extended use in young children might lead to brain damage. The warnings will apply to children aged three years and younger, as well as pregnant women in their third trimester.

Concern has slowly grown over using anesthetics during critical periods of brain development. Repeated use, as well as single sessions lasting longer than ...

continue reading...

Eyes Turn to Delays at FDA Over Heater-Cooler Infection Blame

fda delayed for years on heater-cooler risksWhen it comes to keeping you and your family safe, most Americans would agree that they’d like to think that the agencies with that responsibility are ready to act on their behalf. That, when a problem arises, they will correct the issue and move to solve it quickly and decisively. Not only will they know what needs to be done, but they will do it when it matters most.

By all ...

continue reading...

FDA Not Doing Enough to Protect Women

report says FDA not doing enough to protect women from faulty medical devicesA study conducted by researchers at Northwestern University has concluded that the FDA has largely failed in its responsibility of protecting women from faulty or poorly designed medical devices.

Of the 18 devices approved between 2000 and 2015 for high risk application to women’s medical care; including fetal monitoring, contraception, and uterine bleeding:

  • Four failed to demonstrate that they were actually effective,
  • Six ...
continue reading...

FDA Sued Over Resume Redactions

FDA Sued Over Resume Redactions

FDA sued over redacted resumes of committee membersDefense, intelligence, national security; these are all aspects of the federal government where one expects to see redactions in information released to the general public. We are all familiar with images of government documents with words, paragraphs, or even entire pages redacted, or “blacked out.”

Most of these documents are obtained through what are called FOIA requests, or Freedom of Information Act requests. In 1966, the ...

continue reading...
Page 1 of 13 12345...»