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FDA General
AMA Adopts Policies on Circumcision, Gun Safety
The American Medical Association (AMA) House of Delegates has adopted a number of new policies at its interim meeting, including policies on male circumcision, physician discussion of gun safety, and a new medical coding system that will go into effect in 2013.
Nov 16, 2011
FDA Blocks Sale of Supplements for Parkinson's and Alzheimer's
WASHINGTON -- The FDA filed a permanent injunction against two Minnesota companies that distributed amino acid products marketed as treatments for Parkinson's disease, Alzheimer's disease, and a number of other neurological disorders.
Sep 16, 2011
Medicare to Keep Paying for Avastin
WASHINGTON -- Medicare will continue to pay for bevacizumab (Avastin) when it's used to treat metastatic breast cancer, even if the FDA decides to remove that indication from the drug, a spokesman for the Centers for Medicare and Medicaid Services (CMS) said.
Jun 30, 2011
FDA Warns of High-Grade Prostate Ca Risk With BPH Drugs
WASHINGTON -- The FDA has issued a warning of an increased risk of high-grade prostate cancer with the 5-alpha reductase inhibitors finasteride (Proscar) and dutasteride (Avodart), currently approved to treat benign prostatic hypertrophy.
Jun 09, 2011
FDA Panel Recommends New Rules for Kids' Acetaminophen
SILVER SPRING, Md -- For the first time since they came on the market in the 1950s, children's liquid medicines containing acetaminophen would carry dosing instructions for children younger than 2, if the FDA follows the unanimous recommendation of a federal panel.
May 18, 2011
FDA Panel Rejects Cystic Fibrosis Drug
SILVER SPRING, Md. -- An FDA advisory committee has voted against approval of liprotamase (Sollpura), a pancreatic enzyme product for cystic fibrosis and other diseases that cause pancreatic insufficiency, saying there is not enough evidence that the drug works better than agents already on the market.
Jan 12, 2011
Novartis Settles Civil and Criminal Cases for $422.5 Million
Novartis will pay a $185 million fine for promoting off-label uses of the antiepilepsy drug oxcarbazepine (Trileptal) and another $237.5 million in civil penalties to settle a suit involving Trileptal and five other drugs, the Department of Justice announced.
Oct 01, 2010
FDA Advisers Turn Down New RSV Drug
WASHINGTON -- An FDA advisory committee recommended Wednesday that the agency not approve the investigational drug motavizumab to treat respiratory infections, deciding that it didn't offer any advantages over the drug already on the market, and that it may be more dangerous.
Jun 03, 2010