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Warning Letters

FDA Warns Whoop BPI App Is Unauthorized Device; Firm Says Wearable Is A Wellness Tool

Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.

US FDA Extracts More Evidence To Ban Kratom

Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

FDA Takes World Tour In Recent OTC Warnings

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

Viatris Awaits ‘Significant Rebound’ At Indore In 2026 After Painful Q1 Bite

Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

Digital Health Roundup: Intuitive Surgical CEO Exec Chat, AI Alert System, FDA, Roche New NGS Prototype

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her conference coverage from CES, HIMSS, AAOS and LSI including Exec Chats with Gary Guthart, CEO of Intuitive Surgical, and Arcadia’s chief strategy officer Aneesh Chopra. Brian Bossetta highlights a recently FDA-cleared alert system that sends vital signs to clinicians. Elizabeth Orr discusses FDA warning letters sent to Exer Labs for exceeding marketing claims under what is allowed under the device’s 510(k) clearance. Shubham Singh discusses how Roche's unveiling of its next-generation sequencing (NGS) prototype challenges Illumina. The SBX technology is set to compete directly with Illumina’s NovaSeq and NextSeq platforms.

Viatris Rocked By Indore US Block, With $500m Revenue Sting Anticipated In 2025

Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm’s failure to have its generic version of Revlimid exempt from the restrictions.

Old Problem Of Drugs In Supplements Welcomes US FDA’s Acting Food Chief To New Program

Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.

US FDA Blocks 11 Viatris Products, Except Four With Shortage Concerns

Viatris’ oral finished dose manufacturing facility in Indore, India, was slapped with a US Food and Drug Administration import alert and warning letter.