The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics.
The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics.
The document, entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products—Content and Format,” will apply to the Indications and Usage section for new drugs as well as new indications, or if the label of an already approved drug needs to be revised.
“The indications and usage section should clearly communicate the scope of the approved indication, including the population to which the determination of safety and effectiveness is applicable… In some cases, FDA’s expert reviewers may fairly and responsibly conclude, based on their scientific training and experience, that the available evidence supports approval of an indication that is broader or narrower in scope than the precise population studied,” the document reads.
In addition, the guidance discusses circumstances where it “may be appropriate to consider an indication for an adult population in an age group broader than the population that was studied.” This approach, however, is generally not applicable across pediatric populations or between adult and pediatric populations due to the Pediatric Research Equity Act.
The guidance is part of a series of guidances that the agency has put out or is developing in order to assist developers with the content and format of labeling for drug and biological products.
“FDA-approved labeling is the primary communication tool for providing information on the safe and effective use of drugs to the medical community,” Jacqueline Corrigan-Curay, MD, JD, director of the Office of Medical Policy in FDA’s Center for Drug Evaluation and Research, said in a statement. “This guidance provides recommendations for drafting the Indications and Usage section of the labeling, including a discussion of the scope of an indication and the inclusion of age groups in indications. We believe this guidance will help healthcare providers identify appropriate treatment options for their patients.”
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
FDA Green Lights Second Tocilizumab Biosimilar
March 7th 2024The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: EMA Announces Readiness to Waive Comparative Efficacy Studies of Biosimilars
March 4th 2024Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.
Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates
February 27th 2024Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.