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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog: Biosimilars

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers.

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New regulatory relief to benefit Europe’s pharma SMEs

European Pharmaceutical Review

As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe.

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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Criteria for regulation.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Biosimilars

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Navigating 340B Program Changes in 2025

Proxsys Rx

In a nutshell, says ProxsysRx 340B Optimization Manager Chance Spivey, the CE would have to pay retail prices first to allow for replenishment and THEN submit documentation like they do for 340B ESP (this time with even more claims info). Automate your 340B program with customized software streamlining documentation and reporting.

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NHC Responds to Joint CMS–ASTP/ONC RFI on Improving Health Technology

Putting Patients First Blog

Health management and care navigation applications (apps) should provide a unified experience that allows users to track medications, manage appointments, communicate with care teams, and receive tailored health education. CMS can accelerate access by: Expanding Blue Button 2.0

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NHC Submits Comments on CMS’ Proposed Rule on Marketplace Integrity and Affordability

Putting Patients First Blog

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation. These steps can significantly reduce errors, improve overall compliance, and ensure responsible stewardship of public funds.