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...

$16 Million in FL Pharma Drugs Gone Wron...

In April of this year, the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida requested that U.S. Marshals seize over $16 million dollars worth of prescription drug products that had not yet been approved from Stratus Pharmaceuticals, Inc., of Miami, Florida. These prescription drug products had been marketed and distributed in spite of their lack of approval, which is what prompted this large-scale seizure. The products removed during this operation included topical treatments including; antibiotic skin cleansers, ointments for...