Take Note NDI Notification Filers, US FDA Takes Meetings ‘Before, During Or After’
Pre-filing meetings enhance NDIN process efficiency. “When that notification arrives, it's not a blank slate that you're seeing. The pre-NDI meeting may have been weeks or months ago, but it's information there in the back of your mind,” says acting ODSP deputy director Greg Noonan.
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CDER compliance office director Donald Ashley offers a cautionary note to temper expectations for the FDA’s enforcement in the supplement sector. “We continue to warn the public about products very often sold as dietary supplements that contain hidden drugs,” he says.
UCLA professor Chris Tang says like most US businesses relying on supplies or production from outside the country, particularly from China, consumer health and beauty and personal care product companies should expect at least another year of supply disruption.
Report by American Botanical Council from research by Nutrition Business Journal and SPINS shows sales of supplements with herbal and/or fungal ingredients increased a record 17.3% from 2019, the segment's first double-digit growth in at least 20 years.