FDA proposes new guide for drug labeling

by Christina Sanchez Pharmaceutical Development and Consulting Services

Founded in 1906, the Food and Drug Administration of the United States ( FDA ) is one of the oldest and most important regulatory agencies in the world regarding medicines and their proper functioning to protect people's health. However, the changes that are experienced daily have also forced it to be constantly updated.

In this way, the FDA update its proposal for a new guide on the characteristics of the labels of the medicines that are marketed in the United States. FDA drug labeling guidance that once approved will become the reference that all laboratories should adopt with their products.

Among the main changes proposed, the guide emphasizes that the indications on the label “must accurately reflect scientific evidence, as well as being written concisely to include the necessary information that clearly conveys the uses in which the drug has proven safe and effective. ”

Similarly, the terminology used must be "clinically relevant and scientifically valid and understandable to health professionals." In addition, the labeling must clearly specify the age groups indicated for the medication.

But in case you are interested in knowing the document in full with the proposed new FDA guide , you can do so at the following link.

Drug labeling


The Nutrition Information Label is found on packaged foods and beverages, and can serve as a daily guide for comparing foods and choosing healthy products.

The Food and Drug Administration of the United States (FDA) has launched a virtual tool that facilitates reading further facilitates the reading and interpretation of the information included in the food nutrition information label.

According to the written communication, the FDA's new online tool provides an overview of the nutrition label and an analysis of each nutrient and its role in their daily diet.

In addition, practical recommendations are constantly offered that simplify the FDA's advice on the use of the label to make informed decisions and control those nutrients that we could consume from " more " or " less ."

Information on the nutrition label


Know the various sections of the label and focus on those nutrients that interest you most. Each of them will include information on what it is, where it is located, what it is for and how it relates to your daily diet.

List of ingredients


Find tips for using the list of ingredients found in food and beverage packaging (almost always under the Nutrition Facts Label). The ingredient list helps identify whole grain ingredients, saturated fats and added sugars.

Nutritional glossary


Review common terms related to nutrition, organized in alphabetical order and with simple definitions.



Browse with useful links to additional information from the FDA and other government agencies. This information will help you to continue researching nutrition issues.

Downloadable Information


Download nutritional information you can print to save and share. Download the package of materials or only those dedicated to the elements of the Nutritional Information Label that are of your particular interest.

The new Virtual Nutrition Information Label tool gives you a unique overview of the Nutritional Information Label and each of its elements. Discover and save this new interactive tool in your " favorites" for use in planning your meals and also use it as a reference on your mobile device when shopping.

By using new online tool you will become familiar with the Nutrition Information Label and be able to compare food and beverages, and be more informed to make better nutritional decisions for you and your family.

Why is the FDA approval process important?


FDA approval by FDA regulatory consultants is important because it validates the need for research studies on how drugs work in children, not just adults. It also allows us to determine the appropriate dose for children, determine the best way to administer them and evaluate any interaction between medications.

How does a medication or device achieve FDA approval?


For a medication or medical device to receive FDA approval, the manufacturer must prove to the FDA that the product is safe and effective. Although there is no risk-free medication or medical device, research studies and tests must show that the benefits of the medication or device for a certain condition outweigh the risks that the patient may take when using the product.


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About Christina Sanchez Freshman   Pharmaceutical Development and Consulting Services

5 connections, 0 recommendations, 21 honor points.
Joined APSense since, May 12th, 2019, From New York City, United States.

Created on Nov 6th 2019 00:52. Viewed 265 times.


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