The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products.
The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more
11/3/2023
/ Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Off-Label Promotion ,
Off-Label Use ,
Online Platforms ,
Pharmaceutical Industry ,
Real World Evidence
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Draft Guidance ,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