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Medical Devices

AdvaMed Ideas to Help ASCA Achieve its Promise

AdvaMed makes five suggestions to help FDA improve revised Accreditation Scheme for Conformity Assessment guidances.

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Human Drugs

Hypoglycemia Risk in Novos Weekly Insulin: FDA

FDA medical reviewers share with the Endocrinologic and Metabolic Drugs Advisory Committee their concerns about an increased risk of hypoglycemia in T...

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Human Drugs

Harpreet Singh Leaves FDA for Precision Medicine

FDA Oncology Drugs Division director Harpreet Singh leaves the agency to join Precision for Medicine as chief medical officer.

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Human Drugs

Public Citizen Sues FDA to Force SSRIs Decision

Public Citizen sues FDA to force it to act on a six-year-old petition seeking labeling changes for SSRIs and SNRIs to highlight the risk of sexual sid...

Medical Devices

Hologic BioZorb Marker Recall is Class 1

FDA says the Hologic recall (correction) of BioZorb markers is Class 1.

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Human Drugs

Magellan Pays $40 Million Over Faulty Devices

Magellan Diagnostics (Billerica, MA) agrees to pay $40 million to resolve criminal charges relating to its concealment of a device malfunction that pr...

Human Drugs

PhRMA Supports Post-Approval Safety Guidance

PhRMA says it supports FDA and the International Council for Harmonization revision of the E2D guidance on post-approval case safety reporting.

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Federal Register

Survey on Increasing Pediatric Devices

Federal Register notice: FDA reinstates an information collection entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation...

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Multiple Violations in Akan Bio's Ayama

FDA warns Gaithersburg, MD-based Akan Biosciences about multiple violations in its manufacturing and distribution of Ayama, an adipose-derived stromal...

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Biologics

GSK Reports Positive Data from Asthma Trials

GSK says two Phase 3 clinical trials evaluating severe asthma treatment hopeful depemokimab met their primary endpoints of reducing the annualized rat...