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A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity.
This assists the pharmacist in checking for errors as many common medications can be used for multiple medical conditions. Some prescriptions will specify whether and how many "repeats" or "refills" are allowed; that is whether the patient may obtain more of the same medication without getting a new prescription from the medical practitioner.
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Rheumatoid Arthritis (RA) is an inflammatory disease that's caused by an autoimmune condition. The condition occurs when bodily cells begin to attack and target their own healthy joint tissues resulting in redness, inflammation, and pain. Patients with RA may be given antiarthritics that are used to block inflammation and help prevent joint damage.
Soohoo dutifully followed all the usual procedures to get her medication, including taking a pregnancy test. But this month, she had trouble logging into the iPledge website to check the required ...
In some countries pharmaceutical company have ultimate control of the pricing of their patented product. Therefore, the owner has control of the pricing of the medication, based on the price level the owner deems best to reflects their ability to manufacture and the level of profit desired. Purchasers have little say over the price set. [9]
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