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
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
