Popular Science: FDA User Manual

1. FDA home page structure

After analysis, the homepage can be divided into four zones: functional zone, duty zone, professional zone, and prompt zone. It is actually 4 main indexes, which is convenient for visitors to browse. Most of the districts are intertwined with each other. Now they are introduced as follows.

1.1 Functional Area This is the most commonly used structure for the general website home page (including the home page of personal and commercial websites), with 7 columns.

1.1.1 What's new (what's new) Provides new content and recent changes, mainly to regular visitors to the FDA website.

1.1.2 SMTP Web Site Index is the subject of the FDA sub-directory, in alphabetical order. Such as "about FDA" (About FDA), Acronyms and Abbreviations, Adverse Reactions, Advisory Committees, AIDS, Aging, Almanac, etc. A cursory view can give a general idea of ​​the general picture of the site. Click on the title (such as Aging) to enter the relevant content.

1.1.3 Search Search (FAD Search) helps you quickly find the information you need on your website. Take acyclovir as an example, type Acyclovir, search for "Search All of FDA", and find 127 matches from the site's huge 47,730 articles. The search results respectively list the summary and entry of these documents, and the entry is a blue URL address (http://...), which can be accessed by clicking on the text. If you only care about Acyclovir's status in the FDA's new drug review, you can determine that the search is in the Center for Drug Evaluation and Research (CDER), and the matching literature is reduced to 71.

1.1.4 Frequently Asked Questions List some common questions in question and answer. Divided into four categories: animal drugs, cosmetics, food, FDA general issues. Take the "FDA general problem" as an example. What is the role of the FDA? composition? How to deal with adverse reactions? and many more.

1.1.5 Notepad (Dockets) is equivalent to the FDA's archives, including important events, meeting minutes, and schedules. The author believes that there are two main parts, one is that the minutes of the meeting are open (click on FDA Advisory Committees); the other is the FDA Federal Register Documents. The so-called meeting records are public and are the public meeting minutes of the FDA advisory groups. In order to reflect the openness and fairness in the review of new drugs, some of the speeches of the various advisory groups were recorded and published online. However, these conference records are more than 300 pages, which is a veritable Wenshan Huihai. If you only care about how experts talk about Acyclovir at the meeting, you need to use a search (see 1.1.3) to narrow down the scope. After typing Acyclovir, the search scope is limited to "Dockets", you can find 29 matches from 12,233 Dockets literature, browse the summary (Summy), find the meeting record, click on the entrance, you can know how Mr.XX is evaluated. Acyclovir is gone. Check the Acyclovir's federal registration file for the same operation. The original Acyclovir approval data (in the form of pictures) can be seen online, and even FDA officials scribbled the Acyclovir approval data.

1.1.6 Foreign Language and International Information International (Foreign Language and Interational Information) involves some foreign language versions of FDA regulations and FDA international agreements and activities. Among them, there is not much information on the Chinese version of the FDA regulations, mainly on the import of food and cosmetics. Pharmaceutical companies interested in bringing drugs into the US market can focus on the "Human Pharmaceutical Products: International Activities" in the "International Information Bar", and the legal provisions are up to date.

1.1.7 Contact Contact us (Communicating with FDA) An information desk, and prompt whether you have seen some signs before the inquiry, and listed the signs. Can not find, then write a letter.

1.2 responsibilities area This is the main classification method introduced by the FDA website, all with icons, there are 11 categories, classified according to the scope of management responsibilities.

1.2.1 Foods Chains to the FDA Center for Food Safety and Nutrition, covering the food segment. To ensure food safety and reasonable nutrition services.

1.2.2 Human Drugs Chains to the FDA Center for Drug Evaluation and Research (CDER) are the focus of pharmacy staff. Yang Yaoting [2] has an article on the FDA website that mainly talks about the contents of this column in 1997.

1.2.3 Biologics Chain to the FDA Center for Biologics Review and Research (CBER)

1.2.4 Animal Drugs Chain to the FDA Veterinary Medicine Center.

1.2.5 Cosmetics (Cosmetics) Chain to the FDA Center for Food Safety and Nutrition, involving the cosmetics segment.

1.2.6 Medical Devices and Radiation Health (Medical Devices / Radiological Health) FDA medical devices and radiation to the health center chain (CDRH)

1.2.7 Freedom of information In 1996 there was an amendment to the Freedom of Information Act. The FDA website has done a lot of work on information disclosure.

1.2.8 Field Operations The chain provides management office, import and export policies, contracts, agreements and other relevant regulations.

1.2.9 Children and tobacco The FDA's bill to avoid providing tobacco to adolescents. This column introduces relevant legal provisions and information.

1.2.10 Toxicology Research Chain to the FDA National Toxicology Research Center (NCTR), this column details the mission, equipment, personnel composition, etc. of this center, which is standardized for domestic pharmacology or toxicology laboratories. Building and how to synchronize with the world is a good reference.

1.2.11 Med Watch Also known as the FDA Pharmaceutical Product Reporting Program, it is used to monitor and report on the serious side effects and problems of products already on the market. The domestic adverse reaction monitoring reporting system is similar.

1.3 Special Information is an auxiliary classification system introduced by the FDA website. Is another way to help viewers find the content they need.

1.3.1 Consumers (Consumers) are mainly for consumer spending, such as AIDS clinical trial information services, FDA consumer magazines, mammography information services, food information, seafood hotlines, advice on food and nutrition, and so on.

1.3.2 Industry Some legal information provided by the FDA to pharmaceutical companies and factories, such as import procedures, exports, FDA-related laws, Ombudsman, federal registration, FDA business guidance, etc.

1.3.3 Health Professional There are several columns, including clinical human trial protection rules, drug control and treatment (methadone, etc.), international health action and organization (WHO, etc.), patent related (US Patent and Trademark Office introduction, etc.) , health website introduction (such as infection control website, pharmacy website, auxiliary ā? medical website, food safety website, etc., links to other websites outside the FDA website)

1.3.4 Patients There are some columns that overlap with the consumer section. Although the FDA is not specifically for the medical field, this aspect is an important part after all, so it is listed separately. Topics include topics related to cancer and AIDS, an important description of patient involvement in FDA activities, frequently asked questions and comments, and FDA communication with patients.

1.3.5 State & Local officials The relationship between the federal and state FDA agencies, state FDA agencies and experts.

1.3.6 Woman Provides content and links related to women's health such as breastfeeding.

1.3.7 Children Provide content and links related to child health.

1.4 The hint area is sandwiched between the districts and is an important content and link that the FDA website considers worthy of recommendation. For example, year 2000, Welcome to Internet FDA, FDA Modernization ACT; International Year of Older Persons; HHS (Department of health and human services). HHS is a departmental website closely related to the FDA. It is not a section of the FDA website. The structure is huge and will be introduced separately.

The structure of the FDA website home page is introduced here. It is concluded that the FDA's scope of management involves three main aspects: 1 new drug approval; 2 new drug manual approval and modification; 3 drug production standards. Therefore, the pharmacy information resources of this website are mainly concentrated in these three aspects.

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