About The Post-Marketing Surveillance Of Drugsby Christina Sanchez Pharmaceutical Development and Consulting Services
Post-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.
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.
Created on Aug 21st 2019 14:07. Viewed 256 times.