Topics

Articles

Companies are positioning themselves as approved high-volume compounders

Fourteen compounding pharmacies have already applied for DQSA registration with FDA

CMS posts Sunshine Act registration details

New 'emergent biopharma' service combines compliance with pricing, market access

Consulting firm puts compliance front and center for clinical-stage drug developers

Long-awaited track-and-trace law ushers in a new era of pharmaceutical supply-chain monitoring; compounding pharmacies get a new structure also

Drug Quality and Security Act becomes law

The growing complexity of managed-markets contract support makes outsourcing a near-necessity for Small Pharma, and a better option for Big Pharma

Finding the value in outsourced contract administration

Bill includes voluntary oversight by FDA of outsourced compounded pharmaceuticals, national distributor licensure, and a timetable for serialization and drug tracking

House passes Drug Quality and Security Act; Senate passage is likely

The Medicare Part D switchover of 2007 is only a partial proxy for what the healthcare system will experience in the next several years

Manufacturers should step up their monitoring of consumer healthcare choices under Obamacare

Results of a survey panel by QPharma, presented at PDMA Sharing Conference, show a wide spread of reactions and concerns over agg-spend rules

As the clouds part on Physicians' Sunshine Act, doctors waffle between concern and indifference

UDIs will be in place starting in late 2014, and rolling out over the next four years thereafter

FDA rules for unique device identification (UDI) of medical devices are finalized

While FDA dithers on regulatory guidance, state efforts to anticipate biosimilar regulation are mostly being rejected

Legal and Regulatory