FDA Agency

What to know about our company?

FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use. NEOBIO TECH & JD TRADE CORP, has reached out to companies in Asia to help with every single step of FDA documents including CGMP marks and FDA certified facilities. Our FDA specialist Mr. Henry Park has more than 40 years of experience as an FDA agent. There are many other agents including  Mr. David Mochel, Mr. Jonathan Mckay, and Mr. Brian K. We are currently helping companies in Asia to expand their overseas operations to the United States. We are eager to help those who need help; anyone is more than welcome to contact us at any time to discuss with us about your plan. Again, please feel free to contact us at any given moment.

 What has to be FDA approved?

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. “FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval. 

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    What does FDA approval mean?

FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.

About FDA Product Approval

The Food and Drug Administration’s regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers. Some products — such as new drugs and complex medical devices — must be proven safe and effective before companies can put them on the market. The agency also must approve new food additives before they can be used in foods. Other products — such as x-ray machines and microwave ovens — must measure up to performance standards. And some products — such as cosmetics and dietary supplements — can generally be marketed with no prior approval. At the heart of all FDA’s medical product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions. FDA reviews the results of laboratory, animal, and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself. The Agency does this pre-market review for new human drugs and biologics (such as vaccines, blood products, biotechnology products, and gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs. FDA has streamlined its review process for medical products in recent years to help speed important new treatments to patients. For example, the average review time for an innovative new drug is now only 6 months, and some have been approved even faster.

Approval information by product type

Drugs

Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes)

• Drug Approval Reports by Month

• Drugs@FDA

• Postmarket Drug Safety Information for Patients and Providers

• Prescription Drug User Fee Amendments

Biological Products

Vaccines, tissue, blood, and other products derived from living sources

• Biologics Products & Establishments

Medical Devices

Instruments or products used for treating or diagnosing disease (such as thermometers, artificial hearts, and home pregnancy test kits)

• Device Approvals and Clearances

• Recently-Approved Devices

Animal Drugs

• Animal Drugs @ FDA

• Animal Drug User Fee Act (ADUFA)

• Animal Generic Drug User Fee Act (AGDUFA)

Food Additives

• Food and Color Additives: Final Rules by Year

• Food Additive Petitions for Animal Food