Legal & Regulatory

Newly formed company will create a marketplace where individuals assert ownership of their personal data

Center for Safe Internet Pharmacies builds a coalition to help families; looks into the ‘dark web’

An ‘alternative pathway’ to FDA’s existing expanded access programs?

Eagerly anticipated address avoids major policy changes while chipping away at well-recognized pricing disincentives

Learn the steps for becoming a Verified-Accredited Wholesaler Distributor®

AMA calls for more MAT; HDA calls for better sharing of suspicious-order data

Most proposed solutions are already in the works

Organizations will collaborate on a proposed GS1 standard

‘Shocking’ ease of buying and obtaining delivery of opioids has implications for drug importation

Training, guidelines and enforcement are lagging

Agency plans to issue 'not yet classified' recall notices

TraceLink will oppose the motion

Move unites pharma efforts with larger healthcare network

$5-million settlement resolves six-year-old issue

Washington Post and 60 Minutes question McKesson’s 2017 $150-million fine

IQVIA’s eighth annual survey shows 77% of respondents go beyond compliance reporting

The Netherlands wins out in the competition to move the agency from London

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