The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
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
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
On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more
9/19/2017
/ Congressional Committees ,
Discussion Draft ,
Drug Approvals ,
FDA Approval ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Proposed Legislation ,
Regulatory Reform