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Prior authorization is a check run by some insurance companies or third-party payers in the United States before they will agree to cover certain prescribed medications or medical procedures. [1] There are a number of reasons that insurance providers require prior authorization, including age, medical necessity, the availability of a generic ...
Therapeutic Products Directorate. Pharmaceutical Drugs Directorate (PDD), previously called the Therapeutic Products Directorate (TPD), is a Canadian federal authority that regulates small molecule pharmaceutical drugs for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a ...
Step therapy. Step therapy, also called step protocol or a fail first requirement, is a managed care approach to prescription. It is a type of prior authorization requirement that is intended to control the costs and risks posed by prescription drugs. The practice begins medication for a medical condition with the most cost-effective drug ...
Pharmacist. A pharmacist, also known as a chemist in Commonwealth English, is a healthcare professional who specializes in the preparation, dispensing, and management of medications. [1] [2] A pharmacist provides pharmaceutical advice and guidance, often serving as a primary care provider in the community, and offering other services, such as ...
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to ...
Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA). [4] [5] The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not replace ...
The MHRA manages the Early Access to Medicines Scheme (EAMS), which was created in 2014 to allow access to medicines prior to market authorisation where there is a clear unmet medical need. European Union. Prior to the UK's departure from the European Union in January 2021, the MHRA was part of the European system of approval. Under this system ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common ...