The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of April 26, 2024, announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene....

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing how best to advance the development of new biosimilar biological products (biosimilars or biosimilar products), as part of the Biosimilar User Fee Amendments of 2022 (BsUFA III). As...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #100 (VICH GL 18(R2)) entitled "Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)." This guidance has been developed for veterinary use by the International Cooperation...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Providing Over-the-Counter Monograph Submissions in Electronic Format." This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug,...

The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). For the purpose of this request, FDA is specifically interested in comments on suitable methods to detect, identify, and quantify HCPs, on achievable residual...

The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to Coronavirus Disease 2019 (COVID-19). FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations...