FDA’s MedWatch Program Facilitates Reporting on Suspected, Identified Problems

FDA’s MedWatch Program Facilitates Repor...

FDA pharmacist Captain Catherine Chew recently appeared in a video that advertised the importance of being vocal about problems with medicines during clinical use. On behalf of the FDA, she asked that professionals and patients utilize MedWatch if they suspect or identify issues with medical products within a clinical setting. FDA’s MedWatch program is a tool that will be essential for reporting these serious allegations and issues. “When you report adverse events to the FDA’s MedWatch program, you provide a vital source of information to the FDA. Today, resources are...

What’s in a Name? Medical Spas and the L...

Generally speaking, people consider a medical spa to be a facility that operates under the supervision of a licensed healthcare professional during business hours. This healthcare professional must be operating under the scope set forth by his or her license, and must be available on-site. Furthermore, the other staff members must also be working within the scope of practice as set forth by their licensing board. While this definition seems simple enough in understanding a medical spa or “med spa”, there are certain considerations that potential clients should be aware of...

Domestic Sugar Wars

While my site tends to focus strictly on information regarding pharmaceutical compliance based in Florida, the FDA has recently made headlines for proposed changes to how added sugars are labeled in processed foods that we consume. While food labeling and drug labeling are different processes, it is interesting to observe the process and the reaction of the public on a non-pharma product. The new proposed changes to the Nutrition Facts label began in March of 2014 and the supplemental rules were proposed in the July update of 2015. ONe of the points in particular of this...

The Right to Try in Florida

Over the past year or so, Right-to-Try laws have become increasingly popular throughout the United States. These laws allow patients who are terminally ill to access experimental drugs, biologics and devices that have not yet secured the approvals necessary to be distributed widely. Florida recently approved a Right-to-try law for eligible patients.   Currently, the Right To Try is limited to patients afflicted with a terminal disease who have already tried the traditional treatments but are unable to enroll in a clinical trial. Essentially this is the last option...

How to Adhere to Pharmaceutical Waste Re...

Pharmaceutical Waste Compliance When considering how to properly manage pharmaceutical waste products, there are a few important areas of note. As of 2015, the Environmental Protection Agency has continued the process of outlining and proposing a new set of standards addressing how to handle both the management and disposal of pharmaceutical waste from healthcare facilities. This is meant to enhance the efforts proposed in 2008 when inclusion  of hazardous waste pharmaceuticals in the Universal Waste Program was proposed. Instead of finalizing that initial proposal, the...