The FDA announced on Feb. 28, 2023, it will move cosmetics regulation out of the CFSAN and into the OCS. The move stems from the FDA's broader initiative to reorganize food safety regulation and oversight, as well as allow...more
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more
On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more
4/2/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Marketing ,
Food Safety ,
Health and Safety ,
Hemp ,
Manufacturers ,
Marijuana ,
Marijuana-Infused Edibles ,
Product Labels ,
Public Hearing ,
Regulatory Oversight
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells
In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially...more
On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more
6/8/2018
/ Clinical Trials ,
FDA Approval ,
Institutional Review Board (IRB) ,
Manufacturers ,
Medical Research ,
New Legislation ,
Patient Safety ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Right to Try ,
Trump Administration ,
Written Consent
Many states now permit the use of marijuana for medical or recreational purposes and the federal government has revised certain enforcement policies related to marijuana-related crimes.
The possession, use,...more