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A dramatic shift to e-sampling has been the effective counter to the reduced number of rep visits to physicians’ offices

Preserving Drug Sampling Activity

Recent FDA actions may finally usher in access boost to follow-on biologics in the US 

Biosimilars gain traction with regulators, manufacturers

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

HDA calls for withdrawal of FDA’s latest DSCSA guidance on the ‘enhanced drug distribution system’

Plan aims to offset costs associated with proposed social and health initiatives  

Biden highlights drug pricing reforms to advance legislative agenda

In-house center eliminates the need for a contract manufacturer, company says

Capsida unveils new next-gen gene therapy production site

Open-to-the-public workshops begin on July 28

Partnership for DSCSA Governance releases a ‘Foundational Blueprint’ for managing interoperability

Biden’s executive order targets drug pricing, healthcare costs and health insurance practices

White House renews drive for drug importation

Exploring RCT, RWE and alternative study designs as a path forward

Getting to answers about Biogen’s Aduhelm

Barcode assessment project demonstrates the ground gained in meeting serialization-readiness requirements for supply chain transparency

The march to DSCSA interoperability

“Aggregation” and “inference” are specifically allowed, under draft guidance

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