USA – Guidance : Male Breast Cancer – Developing Drugs for Treatment
This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation...
USA – Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling Guidance...
This guidance is intended to assist applicants in determining the appropriate placement and
content of pediatric information in human prescription drug and biological product labeling...
USA – FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017,...
USA – Vanda Lands OPDP Warning Letter Over Risk Info on Website
The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) last week sent a warning letter to Vanda Pharmaceuticals for failing...
USA – Testing requirements are likely slowing biosimilar entries in the US
Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. Now...
USA – FDA says widening probe on generic drug impurities
The U.S. Food and Drugs Administration said on Wednesday it was expanding its investigation into impurities in U.S. generic drugs beyond a class of...
USA – FDA Officials Explain When Litigation Can Impact Drug Safety Signals
The submission of litigation-associated adverse event reports (LARs) to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) can have an...
USA – FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients...
USA – Woodcock takes charge as acting FDA commissioner
Janet Woodcock, the long-serving director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), is officially the agency’s...
USA – FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal...
Today, the U.S. Food and Drug Administration authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants...
