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FDA Issues Final and Draft Guidance Documents Regarding Food Allergen Labeling

Health Law Advisor

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

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Valencell Unveils Calibration-Free, Cuffless Blood Pressure Monitor

HIT Consultant

Founded in 2006 with a vision to help people live longer, healthier lives, Valencell’s proven inventions, sensor technology, and algorithms can be found in tens of millions of wearable and hearable devices, in over 90 products, for companies such as Samsung, Suunto, Bose, Jabra, Huawei, and Sony.

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What If Costco Designed the Prescription Drugs Sales Model?

Health Populi

Its longer more formal name was The Drug Price Competition and Patent Term Restoration Act of 1984, and it created a pathway for generic drug applications to the FDA. In 2006 the Medicare Part D program was implemented, covering older Americans for prescription drugs for the first time.

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Understanding the 2025 Medicare Part D Re-design: What You Need to Know

Innovaare Compliance

These changes mark a pivotal shift from its original structure in 2006. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. Rebates from the selected drugs may change. Non-applicable drugs (i.e.,

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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. FDA plant inspection and pay $50 million in fines and forfeiture. 10 May 2021.

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Cuffless Blood Pressure Monitoring – Not for the Faint-of-Heart (Pun Intended)

Healthcare IT Today

Moreover, the market for FDA-approved BP monitoring solutions that encourage routine measurements is well into the billions [ 22 , 23 ]. For some R&D efforts, the answer is quite simple – FDA approval has simply not been achievable due to the inability to pass critical performance standards.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

ISO 10651-5:2006, Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

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