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Sharan Murugan
Aug 242 min read
USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information
Yesterday the U.S. Food and Drug Administration (FDA) has released critical guidance documents to streamline the regulatory pathways for...
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Sharan Murugan
Oct 6, 20221 min read
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...
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