Legal & Regulatory

Observers are critical of the $465-million penalty as too lenient

New location, following Brexit, will be decided in November

Meanwhile, opioid manufacturers and distributors contend with multiple DEA penalties

Site lists manufacturers’ policies and criteria for experimental access

95% of consumers don’t know about online pharmacy certification

August, December and February meetings target unresolved technical issues

GAO report notes FDA’s 99% acceptance rate for ‘expanded access’, but legislators press on

The case for a single enterprise-wide learning management system

Late-June announcement gives industry some breathing room for installing product-serialization systems

November 2018 becomes the deadline day for serializing pharma packages

Specialty pharmacy accreditation attracts growing number of pharmacies

Voluntary action—for now; validation of the REMS program

Inceptua Medicines Access carves out a position in supplying pre-approved drugs

Healthcare stakeholders ruminate on the effects of MACRA’s alternative payment models

Context Matters Inc. and IHS Markit provide analytics on pricing strategies

Cutting Edge report finds continued growth in headcount

Compliance officers at pharma companies need to ensure that the right mechanisms are in place for monitoring sales and business incentives

Takes reins with prior experience at both FDA and HHS

Wholesaler-led initiative tags ValueCentric to build an industry data repository; sign in for an April 28 webinar

At Interphex, quick-start programs will be showcased by vendors

QuintilesIMS lawsuit is countered by Veeva’s, claiming antitrust and restraint of trade

Rare-disease drug also garnered a valuable pediatric review voucher

Timely delivery of results will help in GDUFA renewal come October

Meanwhile, Congress strategizes repealing Obamacare, which expanded the 340b program

New consumer-education campaign led by Alliance for Safe Online Pharmacies