A. Executive Summary Health Canada is the federal agency in charge of enforcing the Food and Drugs Act (FDA) and its regulations (FDR), as well as associated policies and guidelines. The monitoring of medication safety continues long after the medicine reaches consumers. Safety issues are identified through post-marketing surveillance, which looks at the effects of drugs on patients after they have been sold in pharmacies across Canada.
Medication errors occur when medications are given or taken incorrectly or by someone with incorrect information about their use. Medications can be harmful if they are not used properly or lost before they reach their destination. Some types of medication errors include: wrong drug given, dose too high, dose too low, drug interaction, allergic reaction to drug, etc.
B. FDA's role In Canada, health authorities work with pharmaceutical companies to identify problems with medications that may lead to adverse events for patients. If a problem is found with a drug after it has been approved by Health Canada, the agency notifies the company and asks them to fix the problem. If the company fails to do so within a certain time period, then Health Canada can take action to remove the drug from the market.
In addition to removing drugs that aren't working or cause serious side effects, governments can also require changes be made to improve the quality of care patients receive.
Health Canada is in charge of approving the sale and usage of new pharmaceuticals in Canada. Health Canada reviews drug safety and effectiveness data from clinical trials for 2 to 4 years before determining whether to approve (or deny) the use of a new medication. If patients are already using a medication and need confirmation that it's safe and effective, their options are to go back to the manufacturer or try another brand. There are also generic versions of approved drugs available on the market.
In addition, Canadians have access to a large number of medications through our health system. Hospitals and other health care providers can order medications for their patients who don't have prescriptions of their own. These medications are called hospital generics because they can be used by any patient in the hospital, even if they aren't listed as having a current prescription with the pharmacy department. Hospital generics are often cheaper than prescribed brand-name medications because they are sold at prices set by the government-funded Canadian Drug Benefit program.
Finally, Canadians have strong rights when it comes to seeking changes be made to existing medications. For example, if a patient feels that a drug isn't working for them anymore, they can ask their doctor to substitute it with a similar medication or switch brands. Neither doctors nor pharmacies are required to do so, but it's important to remember that treatments should be tailored to each person's needs.
FDA In the United States, the FDA is the primary regulatory authority in charge of medication approvals. The agency has a role in preventing harmful effects of medications by requiring drug manufacturers to prove their products are safe and effective before they can be sold. Drugs are classified as prescription medicines if prescribed by a physician and over-the-counter (OTC) if not.
Drugs, including over-the-counter medications, must go through rigorous testing before being licensed for use. New drugs cannot simply be introduced into the market without proof that they are safe and effective. As well, old drugs can lose their effectiveness over time or when used by certain groups of people (e.g., children, pregnant women). To maintain quality control, the FDA requires drug companies to conduct studies on the safety and efficacy of their products after they have been on the market for several years.
These studies are known as post-market surveillance activities. The agency uses information from these surveys to make changes to its regulations if necessary. For example, after-market studies showed that the risk of suicidal thoughts or actions increases with the dose of paroxetine (Paxil), so the label was changed to warn clinicians about this potential side effect.
The Food and Drug Administration (FDA) is in charge of safeguarding and promoting public health. The FDA's new medication approval procedure, like the general drug approval process, is divided into two stages: clinical trials (CT) approval and new drug application (NDA) approval. A third stage called accelerated approval may be granted if a new drug shows promise but further research is needed to confirm its safety and effectiveness.
Clinical trials are necessary before a new drug can be released for sale to the public. They are used to determine whether a drug is safe for use under various conditions and effective against diseases or conditions it is tried on. Clinical trials also help establish the correct dose of a new drug and how it affects different groups of people.
A clinical trial is designed according to four questions: 1 What is the goal of the trial? 2 Who will participate in the trial? 3 Where will the participants be recruited from? 4 With what tools will data be collected? Each question is discussed in detail below.
Goal of the Trial
The purpose of a trial is to find out what benefits the drug being tested provides and what side effects it may cause. Some trials are also done to compare one drug with another or a new drug formulation against a previously approved treatment.
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