Regulatory affairs

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The next act: ACRO, R&D Caucus moving forward with second Cures bill

By Melissa Fassbender

ACRO is collaborating with the Congressional Research and Development Caucus and others to bring forth a new Cures bill focused, in part, on patient engagement, data, and digital health – with draft legislation anticipated early next year.

Outsourcing-Pharma roundup October ‘19

People on the Move: Outsourcing-Pharma roundup October ‘19

By Melissa Fassbender

This month’s people on the move includes a new therapeutic lead at Advanced Clinical, with plans to create a network of investigation sites, as well as CEOs at AIT Bioscience and Pharm-Olam, who discuss plans for moving forward.

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Sponsors need to understand and prepare for CCPA: Greenphire

By Melissa Fassbender

California’s data privacy law will provide clinical trial participants with confidence that their information will not be misused – though additional clarity is needed as the pharmaceutical industry faces mounting pressure to increase transparency.

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Letter to the Editor

Counterpoint: 3 reasons Right to Try is less flexible than expanded access

By Richard Klein, director of expanded access programs and policy, GE2P2 Global Foundation

In a letter to the editor, Richard Klein, director of expanded access programs and policy for the GE2P2 Global Foundation, outlines three reasons why Right to Try is less flexible than expanded access.

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FDA guidance ‘a step in the right direction’

By Melissa Fassbender

The FDA has published the second in a series of guidance documents that aim to accelerate research and the use of patient input to inform clinical development programs, says Iqvia head.

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Product Innovations

Validating The Simoa Technology

Validating The Simoa Technology

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...