1) A.w Re: Topic 1 DQ 1
When a manufacturer wants to put a new drug out to the market to be consumed, they first must pass through the FDA drug review process. This is a twelve-step process that helps ensure the drug is safe for consumers to take. Fist companies will do animal testing and fill out paperwork on what human testing will look like. After that has been approved, they will begin on human trials. This starts out at 20-80 people and increases till it is at 3,000 people. Then the company and the FDA meet to discuss the trials and how they went. The new drug application is placed, and the FDA has 60 days to decide to file it for review. If they approve the review they will go out and evaluate the research on safety and how well it works. They need to also look at how the drug is to be used and the labeling of that. After an inspection of the manufacturing plant, they will decide to okay the drug for approval or complete a response letter (FDA, 2015). When deciding for yourself whether a product is safe to take it is best to look at the information available to you about the FDA study. Most of the tests done look at short term side-effects of a drug. It is important to look at these and decide if they are worth the risk of taking. It is also good to figure out if taking a medication will cause you to take other medications to offset the side-effects from the one you are taking. These are important things to look at when deciding to take a drug. The other worry is long-term side-effects that may not have been found yet. This is something to think about when taking a new drug on the market or if it has been allowed to come out on an emergency trial such as the covid vaccine.
The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident. As a consumer the suggested drug must follow the below procedures before I would trust to ingest according to the US Food and Drug administration. 1) Investigational New Drug Application (IND)–The pharmaceutical industry sometimes seeks advice from the FDA prior to submission of an IND. The number of subjects typically ranges from 20 to 80.2. The institutional review board (IRB) approve the clinical trial protocols, which describe the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications, and dosages to be studied, the length of the study, the study’s objectives, and other details. 3 Phase 1 studies are usually conducted in healthy volunteers. 4) While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. 5) Phase 2 studies ranges from a few dozen to about 300. 6) The FDA uses postmarked requirement and commitment studies to gather additional information about a product’s safety, efficacy, or optimal use and call review meeting. 7) New Drug Application (NDA)–This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. 8-9) Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs.
3) J.W , Hello Professor and class,
The guidelines and red tape used to put out a new drug is very rigorous and many drugs have side effects which could be more problematic than the initial reason for taking the drug. One reason it is so rigorous is because of these side effects. There are some herbal medications being sold which could be less harmful to the body while healing it because they are more biocompatible. An example of these natural over-the-counter medicines is turmeric. Do you think the FDA has different guidelines when processing these medications as compared to Tylenol or Advil and are they more stringent guidelines?
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