Senate cuts follow-on biologics tax cut
The Senate version of recently introduced follow-on biologics legislation, the "Access to Life-Saving Medicine Act" (1S 4016), unlike the House bill, does not include a tax credit for studies performed to demonstrate interchangeability. According to the office of Sen. Hillary Clinton (D-N.Y.), the provision was omitted to avoid a joint referral to the Finance Committee in addition to the Health Committee. Renewal of the Prescription Drug User Fee Act will be under the Health Committee, and Clinton's office believes PDUFA could be a vehicle for follow-on biologics legislation...
You may also be interested in...
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.