How do I check if a drug has been approved by the US FDA? 50

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Search for new drugs and generic drugs approved by the FDA.

The official information of biological products can be queried and understood in the database of FDA approved drugs, mainly for the purpose of querying the label and instructions of drug approvals, seeking the equivalent ** products of innovative drugs and generic drugs or looking for generic drugs of innovative drugs, as well as checking the drug approval history to find all drugs corresponding to a specific active ingredient.

The "U.S. FDA Approved Drugs Database" includes information on 40,000+ drugs approved by the U.S. FDA for marketing and tentative approval in the United States since 1939. You can query drug approval and registration information, drug instructions and related approval documents. The drug information mainly includes:

Trade name, applicant institution, application number, active ingredient, dosage form, route of administration, whether the reference preparation, whether the bioequivalence test control drug, **equivalent**, drug submission type (new drug chemical category) and review category, approval history information, etc. The database is updated in real time and provides multi-dimensional search to help users quickly query the latest approved drugs, target product approval and registration information in the United States, drug instructions and other important information.

FDA-approved drugs.

You can search for keywords by the name of the drug, the active ingredient, the applicant company, the application number, the date of first approval, the date of the latest approval, the dosage form, the route of administration, etc., as well as by the application type, submission type, application route, market status, Chinese enterprise declaration, review channel, and orphan drug.

The first generic drug, reference preparation, **equivalent**, etc., can also be fuzzy screening, precise screening, combination screening, advanced search ("yes, or, non") and other search methods, all-round query of drugs.

For example, if you want to query the information of FDA-approved new drugs in the database, you can select "New Drug Application" in the application type.

You can query the information of new drugs approved by the FDA.

For example, click "Advanced Search" in the lower left corner and enter the drug name "Azithromycin".

Select "and" market status "Prescription Drug" to filter out the data of the FDA-approved drugs in the United States, the drug name is "azithromycin", and the market status is "prescription drug".

FDA approved drug inquiry.

The approval data includes 4 browsing methods: query results, browse by application number, browse by active ingredient, and browse by sponsor.

Click on the global analysis to enter the visualization chart page, which contains the annual trend of drugs (total volume, new drugs, generic drugs, biological product applications), the type analysis submitted, the T10 analysis of the reporting company, the T10 analysis of the active ingredient and other dimensions of the visualization data.

Click "Drug Name" in the query result to enter the drug details page, which contains the basic information of the drug, clinical trial results, drug specification information, NDC catalog information, first approval information, supplementary application information, ** equivalence information, patent information, market exclusive rights protection information, and drug association information.

1. Exporting to the US FDA is not certification, but registration.

2. FDA registration is not a certificate, the product will obtain a registration number by registering with the FDA, and the FDA will give the applicant a reply letter (signed by the FDA chief executive), but there is no FDA certificate.

3. The FDA is a law enforcement agency, not a service agency. If someone says that they are an accredited laboratory under the FDA, then he is at least misleading consumers, because the FDA has neither a service certification body or laboratory for the public, nor a so-called "designated laboratory". The FDA, as a federal law enforcement agency, cannot engage in this kind of work as both a referee and an athlete.

The FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity to those that are qualified, but will not "designate" or recommend specific one or several to the public.

4. When registering with FDA, the Chinese applicant must appoint a U.S. citizen (company association) as its first person, who is responsible for carrying out the process services located in the United States and is the medium to contact the FDA and the applicant.

The code of the product certificate can be checked on the official website of the State Food Administration to check whether it has passed the FDA certification.

Through the FDA, it can only be said that it meets the food safety grade requirements of the United States. However, China has China's product quality requirements, and QS certification is still required in China.

FDA has a huge influence in the United States and even the world, and is known as the "guardian of American health".

Its credibility and professionalism have won the trust of many experts and the general public, and its strict testing and evaluation have not only provided good protection, but also caused criticism from many pharmaceutical and food manufacturers, accusing it of restricting invention and innovation, which is the biggest obstacle to the public's access to special drugs, and lobbying Congress to reduce the FDA's authority, but this practice has not affected the FDA's sacred protection and fulfillment of its mission and responsibilities. Today, the FDA has become the shield of the world's food and drug consumers.

FDA accreditation is required.

The U.S. FDA has the following regulations on personal mail-order of foreign drugs:

1. The number of mail-order foreign drugs should be controlled to meet the maximum dose of drugs for 3 months each time.

2. It is not allowed to resell foreign drugs imported by mail for profit.

3. For drugs that cannot be produced by domestic companies in the United States for the time being, but have been produced in foreign countries, the number of drugs for certain serious diseases (such as cancer, AIDS, etc.) can be relaxed. For example, foreign-produced anti-cancer drugs containing plant ingredients and AIDS treatment drugs (there are fewer such products in the United States) and "alternative drugs" and so on.

FDA certification is divided into many product categories, and the inquiry methods are very different.

For example, medical devices can be directly searched and queried on the FDA official website; The food category requires the enterprise to provide a user name and password to query; Radiation (laser, ionizing electromagnetic, microwave, X-ray, mercury vapor lamp, etc.) cannot be queried on the FDA official website at all, and can only be emailed, mailed, or called the FDA for verification.

The U.S. Food and Drug Administration (FDA) is one of the executive agencies established in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS) in the United States.

As a scientific governing body, the FDA's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products manufactured or imported into the United States. It was one of the first federal agencies to take consumer protection as its primary function.

Responsibility as an FDA-certified scientific governing body.

1. Ensure that food (except for poultry, poultry and some egg products designated by the USDA) is safe, hygienic, hygienic and labeled to protect public health; Ensure the safety and effectiveness of veterinary drugs and vaccines for human use, as well as other biological products and medical devices for human use.

2. Protect the public from the radiation of electronic products.

3. Ensure that cosmetics and dietary supplements are safe and correctly labeled.

4. Adjust tobacco products.

5. Promote public health by helping to accelerate product innovation.