这个发现让我既意外又释然。意外的是，被行业奉为“红线”的CSV验证，竟从未成为FDA的直接处罚靶点；释然的是，这恰好印证了我多年的判断：CSV更多是行业内人为制造的焦虑，脱离这种束缚，才能真正发挥电子实验记录本（ELN）的价值——而这，恰恰契合FDA ...

Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

PMI’s FDA-approved SynCardia STAH is promising, but adoption and revenues lag; cash burn and dilution weigh. Read the full ...

Company Transitions From Infrastructure Buildout to Active Market Execution as Expanded 510(k) Review Enters Final Stages BLACKSHEARS, GA - January 12, 2026 (NEWMEDIAWIRE) - REMSleep Holdings, Inc.

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

Pharma industry experts indicate that strategy in 2026 is shifting to agentic AI, sustainable efficiency, and resilient supply chains to manage tariffs, regulations, and digitalization.

In April, the US Food & Drug Administration (FDA) announced its decision to phase out animal testing requirements for ...

Validated clinical efficacy and scalable manufacturing propel exosomes from research discovery to commercial therapeutics.

GrayMatters Health (GMH), the pioneers of digital brain-region biomarkers for mental healthcare, today announced the publication of new clinical and scientific research that significantly broadens the ...