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FDA Forced to Evolve its Toolkit Amidst Mounting Inspection Backlog during the COVID-19 Pandemic

  Impact of COVID-19 on FDA Inspections The COVID-19 pandemic profoundly disrupted the FDA's inspection capabilities, prompting concerns raised by the U.S. Congress regarding the backlog in assessing pharmaceutical manufacturing facilities[i]. This tumultuous...

Top 5 GxP Controls

The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To address this,  GxP was established and its compliance is mandatory in the healthcare environment. The GxP is a generic term, where ‘G’ stands...

Can the Use of Unlicensed Font on your Website, Marketing Materials, or Packaging amount to a Copyright Breach?

"Type designers are, at their best, the Stradivari of literature: not merely makers of saleable products, but artists who design and make the instruments that other artists use." ― Robert Bringhurst  A good webpage and marketing...

What is and what is not a Software as Medical Device (SaMD)?

The pandemic lockdown has sped up digital transformation in this era. It is increasingly accepted that the availability of certain mobile or web-based apps have helped medical personnel better handle their jobs and allowed patients to access medical information or...
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