2010 - Border inspections and delays for device and import - more FDA presence

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Updated October 15, 2016

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What to Expect Now that the First Big FSMA Compliance Dates Are Here

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Devicemakers and importers can expect delays for inspections and screenings because the FDA is putting their trainees at US borders, reports FDAnews Device Daily Bulletin, Devicemakers May Face More Inspections, Delays in 2010:

"New employees probably will be trained at the borders because that’s where the highest volume of regulated commodities can be found"

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FDA GCP - Tips On Conducting non-US Studies

If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries." The article provides some great tips, not to be overlooked. 

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