Articles
About The Post-Marketing Surveillance Of Drugs
by Christina Sanchez Pharmaceutical Development and Consulting ServicesPost-marketing
surveillance (PMS) is one of the identification and collection of information
regarding medications after their approval by the U.S. Food and Drug
Administration (FDA). Currently, drugs are being developed and consumed at
increasingly high rates. Other factors contributing to the need for Post-Marketing
Surveillance Of Drugs include changes in the FDA’s approval process. The
FDA has responded by developing channels and opportunities for patients in need
to obtain critical drugs. As a result, the dangers associated with the use of
some drugs may not be determined in the premarketing phase.
The Purpose Of Post-Marketing Surveillance
PMS is conducted by different types of
organizations and agencies, including pharmaceutical manufacturers,
universities, government agencies, private companies, and consumer advocacy
groups. The purpose of conducting PMS may differ, depending on the perspective
of the individuals conducting the surveillance. It is including definition and
purpose, available methods, and several examples of the application of PMS in
clinical practice.
FDA combination products
Ø
A combination product is a product composed of two or more different
types of medical products that is a combination of a drug, device, and/or biological
product with one another. The drugs devices and biological products included in
the combination of products. That is referred to as constituent parts of the
combination product.
Ø
One of FDA
combination product’s goals is to assure the availability of quality drugs,
biologics, devices, and combination products that consistently meet applicable
requirements and specifications. The drug CGMPs is used for biologics and
current good tissue practices for HCT/Ps. It also provides a framework of
minimum requirements to help assure product quality.
Ø
This includes establishing a strong quality management system, using
appropriate quality raw materials, establishing robust manufacturing and
control procedures based on sound design principles, and detecting and investigating
product quality deviations. Additionally, these regulations are called for
ongoing assessment of systems and the implementation of corrective actions
where appropriate.
Investigational New Drug Application
The
Investigational
New Drug application is one of the vehicles through which drug sponsors
formally propose. It is the FDA approve a new pharmaceutical for sale and
marketing in the U.S. The
data collected during the animal studies and human clinical trials of an Investigational
New Drug become part of the
NDA. The aims of the NDA are to provide enough information to permit FDA
reviewer to reach the following key decisions:
Ø The drug is safe and effective in its proposed use
and whether the benefits of the drug outweigh the risks.
Ø The drug's proposed labeling is appropriate, and
what it should contain.
Ø The methods used in manufacturing the drug and the
controls used to maintain the drug's quality are adequate to preserve the
drug's identity, strength, quality, and purity.
The documentation need in an
NDA is supposed to tell the drug's whole story. It is including what happened
during the clinical tests and what the ingredients of the drug. It also tells the
results of the animal studies, how the drug behaves in the body, and how it is
manufactured, processed and packaged.
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About Christina Sanchez 
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 Aug 21st 2019 14:07. Viewed 411 times.
