Legal & Regulatory

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

A preamble for a next round of legislating drug pricing?

Just released survey details lack of consensus and difficulties with current requirements

Connecticut leads 20 states suing an alleged ring led by Heritage Pharma

The end of SSFFCs?

Bills passes House with broad bipartisan support; Senate approval likely

Upcoming trial could explore the intricacies of ‘alternative fulfillment’ via specialty pharmacies

Working out these details points to how full compliance will look in 2023

Compliance with the Physicians’ Sunshine Act has moved quickly into obtaining business value

NABP tracks rogue online pharmacies; WHO codifies international testing standards for SSFFCs

US courts fail to clarify when pricing may violate antitrust laws

More evidence that drug abusers are at risk from counterfeiters

CIS by Deloitte seeks to provide a comprehensive service for revenue management

‘Operation Black Market Meds’ involved New York State, Florida and federal investigators

Painkiller addicts buy street drugs that simulate well-known pharma brands

AAPA is positioning itself to provide alternative certification

WDSrx expands controlled substances storage

The growing compliance requirements for distribution call for 
a streamlined approach

New guidance restricts some compounding to other than “essentially copies” of approved products

check on your doc, a company or a form of compensation

Pharma sales practices get raked over again—to what end?

Case falls apart as a 'skeptical' judge calls the company 'factually innocent'