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Draft Guidance ,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 FDA’s Patient Engagement Advisory Committee, organized under the Center for Devices and Radiological Health (“CDRH”), held a public meeting on October 6, 2021, to discuss issues surrounding the...more