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Opioids agonist drugs are a group of powerful and widely used drugs that alleviate the pain of moderate to severe chronic pain by reducing the impact of narcotic receptors in the brain. These include both codeine and hydrocodone, the most common opioids. Although they relieve pain, they have serious side effects that include drowsiness, respiratory depression, dizziness, nausea, and sweating. These drugs are very powerful, so overdoses are common, and death from them is even more common. This group of drugs has received heavy criticism from both patients and doctors alike for the risks involved in using them. The opioid antagonist hydrocodone works by blocking the opioid receptors in the body. Codeine is the only opioid that does this in a pure form. Because hydrocodone blocks the opioid receptors in the brain, it becomes less available to people who take it. This opioid group is popular among heroin abusers, since heroin creates a euphoric state that cannot be reproduced with hydrocodone. For this reason, heroin abusers frequently turn to other forms of treatment, such as prescription medications and methadone. Other opioids agonist drugs in this group include oxycodone, hydromorphone (Percoset), hydromorphone hydrochloride (hydrocodone), and methadone. Taking them is not without dangers though. Oxycodone has caused at least five deaths and several dozen hospital admissions in the US since 1999. In extremely rare cases, people have died of overdosing on hydrocodone. Heroin abusers also regularly take this drug, since it can suppress their desire for heroin. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/02/emergence-of-covid-19-and-increasing.html

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta