Merrell Dow's Seldane
Agency also announced in the Aug. 26 Federal Register that the regulatory review period for the non-sedating antihistamine was 4,614 days -- 3,814 days in testing phase and 800 days in approval phase.
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While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.