The recent release of Colgate Total’s application submitted to the Food and Drug Administration, which included 35 pages summarizing toxicology studies on triclosan, is raising some eyebrows as some are wondering if the FDA did its due diligence in approving Total 17 years ago, according to a report from Bloomberg Businessweek.
The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.
On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.
The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013.
As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.
Capitol Hill staffers this week learned useful tips from a medical expert on reading and understanding dietary supplement labels, and received a primer on the depth of regulation behind dietary supplement labeling during an educational briefing held by the Congressional Dietary Supplement Caucus in cooperation with the leading trade associations representing the dietary supplement industry, the group announced Friday.
A survey co-released on Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that the healthcare providers patients rely on most to explain safety information about their prescription drugs have serious concerns about a proposed FDA rule on generic drug labeling.
Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.
DSN had the opportunity to sit down and talk with Doug Hebert, Co-Founder and Vice President of RxArmory, and Shelly Mowrey, Vice President of RxArmory about the importance of substance abuse prevention.