FDA Publishes Guidance on Labeling Drugs and Biological Products
The guidance provides examples of required and recommended information in the Dosage and Administration section.
FDA published a guidance document on Jan. 16, 2023 intended to assist applicants in developing the Dosage and Administration section of labeling as described in 21 Code of Federal Regulations 201.57, a regulation governing the content and format of the section of human prescription drug and biological product labeling. The applicants should follow the recommendations in the new guidance when developing the Dosage and Administration section for a new drug submitted to FDA under a new drug application under section 505(b) of the Food, Drug, and Cosmetic Act or a biologics license application under section 351(a) of the Public Health Service Act.
The guidance provides examples of required and recommended information in the Dosage and Administration section.
Source: FDA
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
