Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. During that time, FDA has also asserted that it...more
FDA took two important steps last week to clarify the regulatory landscape for cannabis products, including CBD products. First, FDA issued a draft guidance on Quality Considerations for Clinical Research Involving Cannabis...more
7/29/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Clinical Trials ,
Controlled Substances Act ,
DEA ,
Draft Guidance ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Marijuana ,
OMB
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
12/4/2019
/ Adverse Events ,
Comment Period ,
Direct to Consumer Sales ,
Draft Guidance ,
Enforcement Actions ,
Enforcement Authority ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Homeopathic Remedies ,
Marketing ,
New Guidance ,
Pharmaceutical Industry ,
Product Labels ,
Public Health ,
Regulatory Oversight ,
Retail Market ,
Safe Harbors
Recognizing that gene therapy products are now a “therapeutic reality” for some patients, the U.S. Food and Drug Administration (“FDA”) recently unveiled six draft guidance documents intended to foster the development of...more