Malcolm Spicer, Managing Editor – US
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The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.
Sales of its segment leaders Ocuvite and PreserVision vision health supplements, Lumify OTC eye drops and other consumer lines were down a reported 13% to $321m in the second quarter.
As draft guidance receives OMB review, FDA’s determination of no economic significance reflects its official position that the thousands of supplements, food and personal care products containing CBDs available in the US are unlawful.
Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.
A court in Dublin has considered Perirrgo's challenge to Ireland tax authorities' ’ 2018 order to pay $1.9bn additional taxes from its 2013 acquisition of Elan that established it as an Irish firm. “We're just probably within 6 months now that we should get some kind of an answer in that regard,” says CEO Murray Kessler.
Announcing rates for user fees authorized by Food Safety Modernization Act, FDA says supplement and food firms would be charged $263 an hour should agency officials need to re-inspect a US facility in FY 2021 and $310 an hour for facilities in other countries. Without a guidance for small businesses to request lower rates, the fees won't be imposed.