Decision is to be made by FDA within three months on a 1983 submission of a "new claim" for the NSAID, according to an agency memorandum of a Sept. 7 meeting between J&J and FDA. The drug is indicated for "mild to moderate pain" and is currently marketed in Europe
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California proposes limiting short-form Prop 65 warnings to products with 5 inches or less of labeling space, while prohibiting their use in online and catalog warnings. The number of products with the warnings, used even on vacuum cleaners, luggage and guitars, has made tracking them impossible.
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.