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FDA has pedal to the metal on regulations
Tom Stenzel, president and chief executive officer of the Washington, D.C.-based United Fresh Produce Association, made an interesting analogy along those lines at a May 16 workshop of wholesalers and distributors during United Fresh's show.
Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
Oramed Pharmaceuticals Inc. , a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration has cleared the Company's Investigational New Drug application for ORMD-0801, its oral insulin capsule.
3 Most Important Upcoming FDA Decisions of 2013
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West Jordan man pleads guilty to falsely advertising, selling Viagra-like drug
A West Jordan man charged with selling a Viagra-like drug as a natural supplement has pleaded guilty to charges in two separate federal indictments.
FDA approves Roche diagnostic for gene mutation in lung cancer
A logo of Swiss pharmaceutical company Roche is pictured at a company's building in Rotkreuz, April 12, 2012.
Former FDA official on GMO labeling: 'Science doesn't always win'
Whether the food industry likes it or not, when it comes to GMO labeling, the " train appears to have left the station", according to former FDA associate commissioner of foods Dr David Acheson.
Look for new, improved sunscreen labels
FRIDAY, May 10 -- New labeling laws for sunscreen will help American consumers choose the product that provides the best sun protection, experts say.
Teva treads lightly in morning-after controversy
The recent controversy surrounding the morning-after contraceptive pill called Plan B One-Step has been argued in political, regulatory, and legal circles.
There's a running joke about how bad the food served on planes can be, but taste might not be the biggest concern.
Generic Drug Maker Pleads Guilty, Agrees to Pay $500 Million in Fines
Ranbaxy, an India-based generic drug manufacturer, has pleaded guilty to federal drug safety violations and has agreed to pay $500 million in fines to resolve claims that it sold substandard drugs, The New York Times reports.
Janssen Biotech drug gets FDA nod
The Food and Drug Administration approved the use of Janssen Biotech's Simponi for the treatment of moderately-to-severely active ulcerative colitis in adult patients who have demonstrated corticosteroid dependence or did not respond to other therapies.
New drug may help immune system fight cancer
An experimental drug that taps the power of the body's immune system to fight cancer is shrinking tumors in patients for whom other treatments have failed, an early study shows.
Clostridium botulinum fears prompt FDA action
A fear that carrot and beet juice from a US company could be contaminated with Clostridium botulinum has prompted the US Food and Drug Administration to warn consumers about the potential health risks.
FDA approves J&J's Simponi to treat ulcerative colitis
The Food and Drug Administration has approved Johnson & Johnson's drug Simponi for patients with moderate to severe ulcerative colitis, an inflammatory disease affecting the colon.
'Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement'
On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. , a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a global settlement pursuant to which Ranbaxy will pay a total of $500 million to resolve criminal and civil False Claims Act liability.
FDA Approves New Prostate Cancer Drug
Today the US Food and Drug Administration is announcing that it has approved Xofigo to treat men with symptomatic late-stage, castration-resistant prostate cancer that has spread to bones but not to other organs.
FDA approves Algeta's prostate cancer drug
A prostate cancer drug developed by a biotech that's relatively new on the Cambridge, Mass.
Dear Abby: Free family health kits offer news you can use
Dear Abby: When friends and family get together, the conversation often turns to the subject of health.
FDA Issues Pharmacoepidemiologic Safety Study Guidance
FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies, specifically studies that use electronic healthcare data including administrative claims data and electronic medical record data.
Debate: Is The FDA's Caution Hazardous To Our Health?
A team of experts face off for an Intelligence Squared U.S. debate on the motion "The FDA's Caution Is Hazardous To Our Health." When it comes to approving new medical treatments, the Food and Drug Administration is balancing the need for patient safety against the urgency of making important new treatments available as quickly as possible.