Drug product labeling FDA consulting

Drug Product Labeling FDA Consulting

The FDA has a duty to regulate the manufacture, sale, and distribution of both prescription and non-prescription drugs (such as over-the-counter or OTC drugs). A significant FDA role in regulating these drugs is supporting sponsors in their efforts to ensure adequate drug product labeling. In this study, they describe the different types of drug “labeling”…

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Various Duties Of 513(G) Submission

Various Duties Of 513(G) Submission

The medical industries will introduce a lot of medical devices. With the help of that people can get the ultimate benefits.The food and drug administration is invented in the section of 513(g). This section is applicable for federal food, medical and cosmetic device manufacture. It gives proper guidance for submitting, reviewing and responding to the…

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Importance and quality assessment of raw material suppliers

Importance and quality assessment of raw material suppliers

Make known the importance of the evaluation of raw material suppliers in the pharmaceutical industry, specifically.  Objectives:  Know the complete procedure carried out by large pharmaceutical companies to select suppliers of raw materials. Evaluate the impact of the Supplier/Vendor Selection and Qualification on the quality of the finished product. Know the advantages of an adequate evaluation of…

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pma submission

Importance of FDA Pre-Market approval

Premarket authorization (PMA) is a method by which the Food and Drug Administration reviews new medical devices and drugs. PMA is only allowed if the manufacturer can demonstrate safety and efficacy through “sufficient and well-controlled” studies conducted under harsh clinical conditions. Only then can the manufacturer start selling the product. A pma submission is required for any…

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4 steps to develop a Drug Post Launch Activity

4 steps to develop a Drug Post Launch Activity

Drug manufacturing companies may or may not participate in innovative research. They may also be wholly local property or belong to multinational companies or be partially local and partially multinational property. There are a few cases of drug-producing NGOs. The nature of the manufacturing company will determine its attitude towards policies aimed at changing public…

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toxicology consulting

Why the career of pharmacist in toxicology?

It is defined as a science that studies the effects of chemicals on living organisms. It is a science that encompasses numerous areas of knowledge with professionals from various fields.  The toxicological market  Clinical Toxicology: notes patients who remained exposed to a toxic agent. To prevent, diagnose intoxication, and, if necessary, perform therapeutic measures. Occupational…

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