FDA

This week Endo Pharmaceuticals reported that several of its products may experience a "constraint" or "disruption" in supply following the temporary shutdown of Novartis Consumer Health Inc.'s Lincoln, NE, manufacturing facility, where these Endo drugs have been manufactured.

Packaging inconsistencies as well as broken or chipped tablets have prompted Novartis Consumer Health Inc. (NCH) to conduct a sweeping recall.

California’s State Board of Pharmacy (CA BoP) met this week to begin preparing for implementation of the state’s electronic pedigree requirements. CA BoP hosted Connie T. Jung, FDA’s acting associate director for policy and communications in the Center for Drug Evaluation and Research, who explained FDA's goals for a track and trace system. While CA BoP nor FDA did not issue any new policies or make any new decisions, the meeting revealed how closely these two are working together.

FDA directed U.S. marshals to seize all dietary supplements by a Wisconsin maker because of false claims made about their safety and effectiveness in treating a number of diseases, FDA reported on its Web site.

Eager to avoid regulatory mistakes? Attendees at the upcoming MD&M West 2012 conference will get the chance to hear from FDA on warning letters, inspections, submissions, and more. The just-announced line-up offers several FDA representatives along with experienced consultants.

Highlights of the event include the following presentations:

February 14:

Morning: CDRH Top Headquarter Officials Discuss Product Clearances and Quality System Compliance for 2012
Moderator: Nancy Singer, President, Compliance-Alliance, LLC

A combination report from Pharmalive Special Reports explores the current top-selling drugs in the United States as well as reviews new drug prospects. "Top 500 Medicines 2011/New Drug Review 2011" provides details on prescription product sales from 2008 through 2010 and examines the expected market values of new drugs.

This past week FDA participated in Operation Pangea IV, a coordinated international program to root out online sales of counterfeit and illegal medical products. The operation was this year's International Internet Week of Action (IIWA), which is coordinated by INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the Heads of Medicines Agencies Working Group of Enforcement Officers, and national health and law enforcement agencies from 81 participating countries.