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Imbed Raises $10M for FDA-Cleared Wound Care Technology

HIT Consultant

Imbed Biosciences has developed the world’s first and only fully-synthetic and antimicrobial wound matrix, which is FDA-cleared. This FDA-cleared biocompatible polymer matrix creates a healing environment conducive to tissue growth while suppressing harmful microbes and biofilms.

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FDA’s IT Strategy: Unlocking Potential, Leading Transformation

HealthIT Answers

Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency's technological advancement and the alignment with its broader public health mission. By Vid Desai & Jessica N. Berrellez - The U.S.

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Senate Committee’s PREVENT Pandemics Act Draft Released: What to Know

Healthcare Law Today

Improves clinical trials by requiring the Food and Drug Administration (FDA) to issue guidance on the use of digital health technologies in clinical trials; decentralized clinical trials; and other innovative designs to support development of new drugs. Senators Murray and Burr expect the legislation to progress this year.

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Pfizer Acquires Seagen for $43B to Tackle Cancer

HIT Consultant

Seagen Background Seagen is a pioneer in ADC technology, with four of the twelve total FDA-approved and marketed ADCs using its technology industry-wide. Seagen’s medicines, late-stage development programs and pioneering expertise in Antibody-Drug Conjugates (ADCs) strongly complement Pfizer’s Oncology portfolio.

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

Innovaare Compliance

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. CMS will implement negotiated pricing based on maximum fair price (MFP) in 2026 on ten (10) selected drugs. Non-applicable drugs (i.e.,

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A Whole New World for Laboratory Developed Tests – FDA Proposes End to Its Longstanding Policy of Enforcement Discretion

Hall Render

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.