On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist...more
On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”)....more
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Draft Guidance ,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
On July 31, 2018, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services released a portfolio titled “Vulnerabilities in the Medicare Hospice Program Affect Quality Care and Program...more
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are now a “therapeutic reality” for some patients, the U.S. Food and Drug Administration (“FDA”) recently unveiled six draft guidance documents intended to foster the development of...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more