As new technologies continuously push the limits of medical devices and drugs, regulations and governing...
Harmonization
Smartphone-Enabled COVID-19 Test
Becton, Dickinson, and Company, or BD, announced on August 27, that the US Food and Drug Administration (FDA)...
Fiscal Year 2022 Premarket Application User Fees
This past Monday, the FDA announced fiscal year (FY) 2022 medical device user fees. This upcoming fiscal year...
FDA Approves Comirnaty
The day has come where the U.S. Food and Drug Administration finally approves the first COVID-19 vaccination for...
X-Ray Diffraction, a Useful Characterization Technique
X-ray diffraction (XRD) is a non-destructive laboratory technique that assesses the lattice spacing of crystalline...
Pharmaceutical Temperature Mapping
Temperature mapping has become increasingly integrated into regular operations for those who produce or handle...
ISO 13485 & QSR Harmonization
For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...
EU’s New Guidance on Harmonized Standards
The EU Commission released a new guidance document clarifying the purpose of harmonized standards under the EU Medical...
The USMCA Agreement
FDA played a key role in the negotiations of the United States-Mexico-Canada Agreement. The agreement entered into...
Application of Harmonized Vs Latest Version of Standards
Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the...
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