The U.S. Food and Drug Administration (FDA) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, to contribute evidence of...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
3/15/2024
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Informed Consent ,
Penalties ,
Reimbursements ,
Research and Development ,
Risk Mitigation ,
Shareholders
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more
12/7/2023
/ Advertising ,
Amended Regulation ,
Direct to Consumer Sales ,
Enforcement ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements