The Latest Episode of the LDT Drama: FDA Issues Long-Awaited Proposed Rule for Laboratory Developed Tests
The Latest Episode of the LDT Drama: FDA Issues Long-Awaited Proposed Rule for Laboratory Developed Tests
FDA Issues Draft Guidance on Good Clinical Practice in Ongoing Clinical Trial Modernization Efforts
FDA finalizes guidance on voluntary recalls, issues recommendations for industry
FDA clarifies evidence and knowledge requirements in intended use final rule
Marketers Beware: As COVID-19 cases increase, FDA, FTC increase efforts to crack down on fraudulent and deceptive marketing and sales of purported ‘Virus Cures’
FDA’s Section 804 Prescription Drug Importation Program and 801(d)(1)(B) Guidance
FDA revamps cybersecurity guidance for marketed medical devices
FDA to implement OIG suggestions on IoT cybersecurity
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