Writing: The FDA Compliance Problem No-One Talks About

There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But when it comes regulated manufacturing operations, the FDA’s rule of thumb is that... Read more

New DRAFT FDA Guidance Published Today – Nonbinding Feedback

Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding "non-binding feedback" after FDA inspections of certain medical device establishments. Limited to statutory (FDARA 704) situations involving a "public health priority", "implicat[ion] of systemic or major actions" or... Read more

POPULAR SCIENCE; BAD JOURNALISM

Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a company’s characterization of what can best be considered a sham product as a... Read more