News

European anticounterfeiting project tests end-to-end authentication

Launch includes a delayed-release formulation, in-house and contract sales force, a REMS program and a patient-adherence program

Kaiser Permanente files a citizen’s petition to revise FDA’s process of imposing REMS programs; also objects to restrictions on wholesale-distribution

CRM vendor invests in data sources to upgrade its offerings for life sciences regulatory and marketing operations

Sharps Compliance Corp. lauds California law to raise the profile of proper consumer disposal of used sharps

Participants will meet quarterly throughout the year to create supply chain use-scenarios with GS1 standards

Updated survey finds some improvements, but little overall progress since a 2006 survey

In the past year, FDA has imposed REMS programs for one out of four new drug approvals

Impersonators appear to be operating from the Dominican Republic

With limited IT resources, the company is rolling out one business-intelligence application after another

Enterprise resource planning

FDA’s requirements for risk evaluation and mitigation challenge both new and existing commercialization processes

‘Print on demand’ changes traditional design, production and inventory practices for labels, inserts and other printed packaging

The signs are apparent that there is organized criminal activity focused on pharma logistics By Nicholas Basta

A review of 84 branded pharmaceutical products with changed ownership as of 2005 shows that many of them can continue to sell, often with much higher prices By Albert I. Wertheimer, PhD, MBA, Temple University, and Ellen F. Loh, BS, MBA, University of Maryland, Baltimore

Survey shows close interplay between manufacturers and their trading partners for supplemental services

UPS gets ready to receive GS1 product-tracking data from anyone

Fifteen of top 25 are drug or device makers; hospitals and distributors round out the list from the new Gartner subsidiary

Addition of EZ-Cart system drastically cuts restocking efforts

The dilemma: packaging a drug for a condition that makes self-administration difficult

The current FDA policy toward REMS is being challenged by Allergan

The basic process of defining customer segments and appropriate promotional messaging benefits from a cross-disciplinary approach

Schering-Plough implements packaging line vision technology with a view toward future data collection needs

FDA sets a precedent for granting generic approvals even when initial litigation goes against the generic manufacturer

Congress votes it down, but Obama Administration still holds onto its prospect

Two-year-old merger of three regional associations is a victim of changing marketing priorities

Derycz Scientific announced deal with Cubist Pharmaceuticals for medical literature access