My strategy as a health care administrator communicating with Get Well Drugs is to evaluate new drugs before they can be sold. Center for Drug Evaluation and Research (CDER's) evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.
First, I will test the drug to make sure it is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center will not actually test the drugs, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. Clinical trials are experiments that use human subjects to see whether a drug is effective, and what side effects it may cause. New drugs, like other new products, are frequently under patent protection during development. When the patents or other periods of exclusivity on brand-name drugs expire, manufacturers can apply to the FDA to sell generic versions. If FDA finds a problem, it can order a”clinical hold" to delay an investigation, or interrupt a clinical trial if problems occur during the study.
I would ask questions directed toward Get Well drugs such as; Does the FDA require that animals of both sexes be included in non-clinical studies? The difference between species often has a greater influence than the difference between sexes, so our recommendations will vary depending on product area. I own a pharmaceutical business. Am I eligible for, and if so, how do I apply for a Prescription Drug User Fee Act (PDUFA) waiver? The Agency will waive the application fee for the first human drug application that a business or its affiliate submits for review. After a waiver for a first human drug application is granted, the business is assessed appropriate user fees for all subsequent human drug applications and supplements submitted for review. There are no business waivers for product or establishment fees. To be granted a waiver, the business must submit a written request for the waiver. What advice do you have to new companies regarding good manufacturing practices? To manufacture drugs, a company must register with FDA and comply with current good manufacturing practice regulations. We recommend that they consult with experts in pharmaceutical manufacturing regarding the latest innovations in complying with these requirements.
The Bad Ad Program is an FDA-sponsored outreach program designed to educate health care professionals about the role they can play in helping FDA ensure that prescription drug advertising and promotion is truthful and not misleading. The program helps health care professionals who prescribe medications or otherwise make selection decisions about the use of prescription drugs for patients (including physicians, nurse practitioners, nurses, physician assistants, and pharmacists) to better understand what constitutes appropriate prescription drug promotion and advertising and how to report possible violations.
The program seeks to increase the effectiveness of OPDP's surveillance program, especially with regard to curtailing inappropriate promotional activities of sales representatives visiting the offices of health care professionals and delivering presentations to health care professionals...
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