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Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ
An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to…
Watermelon Water – New Fad, but FDA Approved?
ABC news and other media outlets are reporting on a new beverage fad – watermelon water. Before jumping on the bandwagon, it is important to…
Data Integrity and Form 483 or Warning Letters
Data integrity is an essential component of both clinical and nonclinical research conducted under the supervision of the Food and Drug Administration.
New FDA E-Cigarette Rules – What Does It Mean
Yesterday (April 24, 2014) the US Food and Drug Administration (FDA) announced new regulation of e-cigarettes. The rule changes the FDA’s prior position of only…
Nearly 25% of 2014 Warning Letters Issued to Seafood Industry
A warning letter issued by the US FDA is the most common and widely used enforcement tool. It is also among the most public. Every…
FDA Proposes New Nutrition Label
The US Food and Drug Administration announced today dramatic new changes to the food nutrition label. The proposed label is open for comment over the…
FY 2013 483 Data Released; Top Ten Observations Unchanged
The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement…
FDA Publishes Draft Approach to Identifying High Risk Foods Under FSMA
The US Food and Drug Administration announced its
New FSMA Rule; Proposed Rule on Sanitary Transportation of Human and Animal Food
The US Food and Drug Administration announced a new rule to prevent food safety risks during the transport. This is the seventh and final major…
FDA Issues Two New Guidance Documents; Energy Drinks and Liquid Dietary Supplements Under New Scrutiny
The US FDA issued two new guidance documents focused on energy drinks following a Congressional call for action.
Marijuana, THC, and the US FDA – What Does Increasing Legalization Mean for Food, Drugs, and Dietary Supplements?
Colorado made headlines this past week when its decriminalization of marijuana went into effect. Since that time an increasing number of calls and e-mails rushed…