FDA
FDA Shutdown – Preparing for the Likely Government Shutdown
***UPDATE: Congress approved a short term budget deal that will fund the government through December 11th. There remains a liklihood that a FDA shutdown could…
FDA Warning for Kim Kardashian
A Lesson in paid and un-paid user testimonials It is a bit of a surprise to write about Kim Kardashian on a FDA regulatory blog….
Regulatory Planning for FDA FY 2016
The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1 through September 30. The new FY brings…
FDA SEC Reporting – Regulatory Reviews for SEC Forms
FDA SEC Reporting Regulatory Reviews in Form 8-K FDA SEC Reporting does not readily come to mind when considering foods, dietary supplements, drugs, cosmetics (so…
FDA Regulation of Homeopathic Drugs – Meeting Foreshadows Changes
FDA Regulation of Homeopathic Drugs Current Regulation of Homeopathy The FDA currently regulates homeopathic drugs under a 1988 Policy Guide. The Policy Guide is detailed…
Nutrient Content Claims + KIND Warning Letter
What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of the KIND snack bar with a recent…
FDA Warning Letters
The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters are common food,…
Cuban Cigars and the FDA
With the announcement today by US President Barack Obama that the United States will begin to normalize relations with Cuba a number of questions come-up….
Review: FY 2014 Inspectional Observation Summaries
At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the…