FDA Releases DSCSA Guidance Plan for 2016

FDA Releases DSCSA Guidance Plan for 201...

The U S Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) recently released insights regarding off-label communications, generics products, and pharmaceutical quality. More importantly, the FDA released the Drug Supply Chain Security Act (DSCSA) guidance plan for 2016. There are 15 categories of guidance documents planned for 2016. Included: advertising, biopharmaceutics, biosimilarity, clinical/antimicrobial, clinical/medical, clinical pharmacology, clinical/statistical, drug safety, electronic submissions, generics, labeling,...
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...

New Software Injects New Life into Pharm...

SAP, the largest global provider of Enterprise Application Software recently announced their newest software module currently called, “SAP Advanced Track and Trace for Pharmaceuticals”. Also known as ATTP, this new module from SAP is an enterprising new competitor to third party solutions that allow companies to serialize their products in a way that complies with global serialization and tracing regulations for pharma products. Currently, drug companies utilize a system that incorporates multiple modes of serialization and tracking products, and often requires these...

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...