Examples of FDC in a sentence
It extends the FDA's "tobacco product" authorities to "all other categories of tobacco products meeting the statutory definition of 'tobacco product' in the Federal Food, Drug, and Cosmetic Act (FD&C Act), except accessories of such products." The newly regulated products include currently marketed products (e.g., electronic cigarettes, cigars, waterpipe (hookah) tobacco) and future tobacco products.
The products subject to these marketing granted orders are subject to withdrawal or temporary suspension as described in section 910(d) of the FD&C Act.
Table 2 – Varying Regulations and Policies Relating to ClinicalTrials.govElementFederal Regulations (42 CFR 11)NIH PolicyICMJE Policy Scope/ApplicabilityApplicable clinical trials of FDA-regulated drug, biological, and device products and pediatric post-market surveillance studies of devices required by the FDA under the FD&C Act.
The Deeming Rule requires these tobacco products to comply with all provisions regarding "tobacco products" found in the FD&C Act and FDA regulations.
Having concluded that the criteria for revocation of the Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA for bamlanivimab and etesevimab administered together.