Development, FDA Approval and FDA Compliance

FDA Refines Accelerated Approval Pathway with New Draft Guidance

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

Clinical Trials

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Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

AUGUST 19, 2024

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. What is the purpose of a Design History File (DHF) in medical device development? CE marking in the EU, or TGA approval in Australia. Regulatory bodies such as the U.S.

Compliance

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Clinical Research Informer

FDA Refines Accelerated Approval Pathway with New Draft Guidance

Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

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