HDA calls for withdrawal of FDA’s latest DSCSA guidance on the ‘enhanced drug distribution system’
FDA’s recommended guidance is for a system that ‘does not exist, cannot be built by 2023, and poses unacceptable security and compliance risks,’ says alliance
FDA releases more guidances for complying with DSCSA
“Aggregation” and “inference” are specifically allowed, under draft guidance
Ruling made in latest round of litigation over alleged data theft
Pair of life-sciences data powerhouses are immersed in dispute over their respective data services for pharma sales and marketing
Pharma logistics’ post-pandemic landscape
Nationally and internationally, the logistics service providers for life sciences see a new vista
One door closes; another one opens…
Spinning up the pharma traceability wheel
Steady progress is occurring in the global effort to track pharmaceutical distribution, even as new technical and business opportunities appear
Patient support / hub services continue to evolve
The goal of producing meaningful data is driving industry progress
Cellular and genetic therapies push into the commercial arena
Even as the science behind the new therapies is getting established, payers are preparing for their extraordinary cost
Pharma traceability lumbers along
A 2017 postponement makes 2018 the key year for serializing US products; authentication makes a comeback, and cargo security goes digital
The Hub Services Wheel keeps Rolling Along
Patient support (hub) services rise in lockstep with specialty pharmaceutical launches
Orphan drug market gets some bruises in the commercial arena
High prices and questionable marketing activities muddy an otherwise bright picture
Advancing the biopharma cold chain
Vendors and service providers scramble to serve a growing market
A Conversation with Mark Merritt, Pharmaceutical Care Management Association
2016 Product Security Report
Pharma spends heavily to secure its supply chain, while politicians bring out the re-importation topic
Hub Services Special Report 2016
Connectivity with patients drives pharma growth
Specialty pharma becomes 'hub enabled'
A Conversation with Matt Wallach, Veeva Systems
A master data management revolution: MDM for everything digital
Dramatic changes are seeping into how pharma companies manage diverse datasets
Logistics providers confront a complex, global healthcare market
The rise in product volume is more than matched by the rise of regulatory constraints
Pharma logistics--so what?
Looking at the essential value of well-managed supply chains
A Conversation with Bill Roth, Blue Fin Group
Biosimilars: what's in a name?
While FDA tries to referee the naming conventions for biosimilars, different factions of the healthcare system weigh in with conflicting priorities
Drug pricing will be a hot-button issue in this election cycle
A Conversation with George Barrett, Cardinal Health
Traceability mandates surge through global supply chains
Packaging-line engineers are going into overdrive as industry gets ready for the 2017 unit-serialization mandate
A Conversation with Steve Collis, AmerisourceBergen
The quality drive at contract manufacturers
Contract development and manufacturing organizations (CDMOs) want to be more reliable business partners to pharma
Building a cold-chain data network
Technology and regulations drive shippers toward more data collection and reporting
The Phase III pricing experiment
Product launch--the 21st-century way
New IT tools are propelling a more focused approach to product launch