Why Did FDA Approve Two Diet Drugs Banned in Europe?Writing in the journal BMJ this week, Dr. Sidney Wolfe, a leadingand outspoken consumer health...Perry, Susan
“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs," said Jim Jones, the FDA's deputy commissioner for human foods. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly,...
A key goal, and major question mark, is Congressional appropriations for the Human Foods Program overall and the office that oversees dietary supplements. “FDA is two parts, drugs and foods, to make it simple,” said Israelsen. “Drugs are largely funded ...
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions. The FDA has several big decision deadlines coming up, including two for blockbuster drugs seeking to push into new indications and one that could ...
The Food and Drug Administration today banned some uses of the color additive Red No. 3, saying studies have shown that in very high doses it causes cancer in laboratory animals.
The tentative agreement, which must be approved by a U.S. court, calls for the company to keep servicing apnea machines already being used while stopping to sell new ones until specific conditions are met. After an initial recall announced in June of 2021 to repair or replace about 5.5 mi...
Also rare is pushback on an FDA proposal to withdraw ANDA approval, but we have that too right now in the context of applications for the prescription laxative Polyethylene Glycol 3350 (see our previous post here). Categories: Hatch-Waxman | Prescription Drugs and Biologics HP&M’s Karla ...
As the ANH points out, the FDA recently banned a common form of vitamin B6 by claiming the vitamin was a "drug" that was never "approved" for use in supplements (http://www.anh-usa.org/when-is-a-vitamin-not...).That story is also covered here on NaturalNews: https://www.natural...
The laws that resulted are both more complex and less demanding than those governing drugs. To win FDA approval, for example, most new prescription drugs undergo two large, rigorous clinical studies proving they benefit patients. But most new medical devices enter the market with no clinical t...
I’m highly sympathetic to the idea that there should be a better way to promote FDA approved drugs known to be effective for some off-label use to a similar status as those that have passed a phase III trial. Whatever it is, it’s going to have to balance the needs of patients, ph...