Medical Innovation Exchange

RC – Regulatory Management RIM

Registration Opens for March IMDRF Meeting in Washington, DC

Registration Opens for March IMDRF Meeting in Washington, DC     Industry members and other stakeholders are invited to register for the 25th session of the International Medical Device Regulators Forum (IMDRF). The FDA, as the Chair and Secretariat of IMDRF, will be hosting this year’s session at the Ronald Reagan Building & International Trade Center …

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Key Barriers to RWD Adoption

Key Barriers to RWD Adoption     Complex data curation and lack of knowledge on patient care settings and behaviors are among the key barriers to widespread adoption of real world data in life sciences, according to the results of a recent survey commissioned by Komodo Health and conducted by Frost & Sullivan. The survey, which was …

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European Commission Proposes Extension for EU IVDR Compliance

European Commission Proposes Extension for EU IVDR Compliance     On January 23, the European Commission put forth a proposal that would extend the deadline for compliance with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. The Comission noted that its goal in revising the deadline is to ensure patient care by improving …

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Regulatory Advocacy: Amplifying Your Voice

Regulatory Advocacy: Amplifying Your Voice     Medical devices and pharmaceuticals are heavily regulated. In the U.S., stakeholders have opportunities to communicate with regulators through pre-submission meetings, commenting on proposed regulations and draft guidances, and working with industry trade associations. But what is the right path for your particular company or concern? During the 2023 MedTech …

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FDA Announces New Genetic Metabolic Advisory Committee

FDA Announces New Genetic Metabolic Advisory Committee     The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for the diagnosis, prevention or treatment of genetic metabolic diseases under the purview of the Division of Rare …

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