Regulatory

FDA has approved the new drug application for Abilify MyCite (aripiprazole tablets with sensor) to track drug ingestion.Abilify MyCite was approved for treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar...

Medical device packaging professionals are well acquainted with ISO 11607, Parts 1 and 2. But how about ISO 10993-18?ISO 11607 has guided medical packaging development for about two decades. The standard “outlines the requirements for both...

The National Bioengineered Food Disclosure Law—signed into law on July 29, 2016—directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July...

Audits of quality systems are required in the medical device industry—but are you conducting your own internal audits on a routine basis? Are you including your packaging operations?Internal audits at planned intervals are expected under 21 CFR...

Labeling of genetically modified (GM) food products (so-called Franken foods, according to their critics) has been a hotly contentious issue for at least 20 years now. It has only been in the last few years, though, that momentum built at the...

Pharmaceutical packaging suppliers have just one year before all U.S. Drug Master Files (DMFs) will need to be submitted electronically. As we explained earlier this year, DMF submissions and related documents will need to be filed electronically...

Pharmaceutical manufacturers have been submitting applications electronically to FDA for years. So the agency’s announcement that it intends to switch its current paper system for accepting Drug Master File (DMF) information to an electronic one...