Tags » FDA Regulations

Principles of FDA requirements for medical devices

The FDA has some clear-cut requirements that those manufacturing medical devices have to meet in order to get their products approved. FDA requirements for medical devices cover regulations for these devices, based on the way they are classified, and for meeting set regulatory guidelines. 505 more words


What is a quality assurance unit?

Suppose you were just hired in a Quality role (QA specialist, tester, auditor, inspector, reviewer, technical data specialist, etc.). During your orientation and training people bandy about such acronyms and initialisms as the GLPs, the OECD, the QAU, and 21 CFR 58. 1,105 more words

Big Government Strikes Again

Thanks to crushing new FDA regulations on the cigar industry, one generations-old factory may be forced to shut its doors for good. The owners of Tabanero Cigars in Tampa, Florida say they’re already feeling the pinch. 47 more words

Cigar News & Comment

Super Important: Most Supplements Don't Contain ANY of the Listed Ingredients.

This isn’t remotely related to the topics I normally cover, but it’s something we need to spread the word about. I first heard about this back in 2015, but since the information hasn’t spread to the general public yet, I want to give it a signal boost. 323 more words