The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.
The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.
Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.
Only 1-in-5 U.S. adults are meeting both the aerobic and muscle strengthening components of the federal government's physical activity recommendations, according to an article published Thursday in Morbidity and Mortality Weekly Report, a journal of the Centers for Disease Control and Prevention.
The Justice Department reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.
The Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older.
Consumer Reports recently corrected a story to run in its May issue, titled “Vitamin D: How 32 supplements really measure up," that erroneously identified nine vitamin D/calcium supplement products that the publication claimed exceeded the California Proposition 65 Lead Limit for Reproductive Risk.
The National Advertising Division last week recommended that Interhealth Nutraceuticals discontinue certain claims for the company’s Zychrome dietary supplements, products that are promoted for the management of insulin levels.
Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.
More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.
The Marketplace Fairness Act is one step closer to passing. The Senate voted 63-30 to end debate on the bill, which would compel online retailers to collect state taxes, and will make a final decision on the bill on May 6.