In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more
10/19/2022
/ Abbreviated New Drug Application (ANDA) ,
Adverse Events ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare Workers ,
Labeling ,
Manufacturers ,
Over The Counter Drugs (OTC) ,
Prescription Drugs ,
Proposed Rules ,
Reporting Requirements ,
Retailers ,
Strict Product Liability
Key Takeaways - The COVID-19 pandemic led the U.S. Food and Drug Administration (FDA) to pause most foreign and domestic inspections and begin conducting remote interactive evaluations. FDA has since issued a written policy...more
Key takeaways - FDA is soliciting feedback on a proposed framework to change medical device labeling to require long-term devices to identify all constituent materials that might come into contact with human tissue and to...more