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FDA Softens August 2025 NDSRI Deadline—Progress Reports Now Accepted

The FDA Law Blog

Per FDA’s update, non-application products without annual report requirements should prepare similar documentation and retain it for FDA inspection requests. Monitor FDA communications, including the aforementioned webpage, as the Agency may put forth revised timelines and new/revised guidance based on submissions.

FDA
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Top 10 RPM Vendors 2025: Driving Results in Remote Patient Monitoring

PharmD Live

PharmD Live’s board-certified clinical pharmacists manage and monitor the RPM service, record and document patient health metrics, and provide monthly billing reports, reducing provider workload without sacrificing care. PharmD Live blog. AMBCI Medical Billing & Coding Certification Blog. Published June 4, 2025. PharmD Live.

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More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

The FDA Law Blog

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.

FDA
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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

The FDA Law Blog

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). In such cases, performance testing may be conducted again.

FDA
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“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

The FDA Law Blog

For example, while FDA updated certain guidance documents to remove terms offensive to this administration, like gender, since the start of Trump 2, not a single new device-related guidance has been issued. Industry relies on guidance documents to understand the Agencys current policy and practice.

FDA
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To Meet or Not to Meet: Day 70 and Counting

The FDA Law Blog

Newberger — Recent communications from CDRH indicate that impacts to resources from Reductions-In-Force are causing some Offices in CDRH to delay granting a request for a pre-submission (or Q-Submission) meeting until after written feedback is provided. By Véronique Li, Senior Medical Device Regulation Expert & Jennifer D.

FDA
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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

The FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.