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...

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...