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Sharan Murugan
- May 11
- 1 min
USFDA Med Dev: Guidance on Remanufacturing of Medical Devices
Recently (09 May, 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released the...
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Sharan Murugan
- May 11
- 2 min
USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
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Sharan Murugan
- May 6
- 2 min
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...
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Sharan Murugan
- May 1
- 2 min
USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
Yesterday (30 April 2024), the FDA released a draft guidance for the industry titled "Considerations for the Use of Human-and...
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Sharan Murugan
- Apr 27
- 2 min
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and...
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