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.
Means
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.
Source:
https://pharmaceuticaldevelopmentgroup.home.blog/2019/11/06/fda-proposes-new-guide-for-drug-labeling/
https://pharmdevgroup.hatenablog.com/entry/2019/11/05/151250
https://medium.com/@kellyshelton602/fda-proposes-new-guide-for-drug-labeling-920e891ade11
http://pharmaceuticaldevelopmentservices.booklikes.com/post/1985269/fda-proposes-new-guide-for-drug-labeling
https://www.evernote.com/shard/s366/sh/4775d2d1-f176-4dd8-bdc3-46061b9cb3a5/a0db078677ede8c9d7c0399655a14bc4
http://www.apsense.com/article/fda-proposes-new-guide-for-drug-labeling.html
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