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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...
Sharan Murugan
Aug 24, 20242 min read
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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...
Sharan Murugan
Oct 6, 20221 min read
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