Legal & Regulatory

Wholesaler members ready themselves for DSCA-compliant returns processing in 2019

Counterfeit opioids and fake medical devices were a focus in the annual take-down of illicit distributors

Better accounting of sample distribution is offered

TraceLink charges HDA with antitrust activity over its Origin database

Intent of the 2016 Ensuring Patient Access and Effective Drug Enforcement Act is questioned

The Sharing Conference returns to Baltimore in 2017

PDUFA reauthorization creates new pathways; GAO report notes FDA’s 99% acceptance rate for expanded access

Master data on prescribers is combined with tracking expenditures, for transparency reporting

An estimated 64,070 deaths recorded; meanwhile, private equity flows into addiction centers

Pharma needs better internal policies to manage its increasing patient interaction

In the midst of the opioid crisis, drug distributors need to address DEA oversight

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