FDA services and consulting, guided by an FDA specialist with 40+ years of agency experience.
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.
Neobiotech & JD Trade Corp has reached out to companies in Asia to help with every step of the FDA documentation process, including cGMP marks and FDA-certified facilities. Our FDA specialist, Mr. Henry Park, has more than 40 years of experience as an FDA agent. Additional agents include Mr. David Mochel, Mr. Jonathan McKay, and Mr. Brian K. We are currently helping companies in Asia expand their overseas operations into the United States. Anyone is welcome to contact us at any time to discuss your plan.
The FDA is responsible for protecting 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 the food supply, cosmetics, and products that emit radiation. "FDA approved" means the agency has determined that the benefits of a product outweigh its known risks for the intended use. Manufacturers must submit a premarket approval (PMA) application along with clinical testing results.
FDA does not develop or test products itself. Instead, FDA experts review the results of laboratory, animal, and human clinical testing conducted by manufacturers, and grant approval when the benefits of the product are determined to outweigh the known risks for its intended use.
The FDA's regulatory approach to marketing approval varies as widely as the products themselves, shaped by the laws it enforces and the relative risk each product poses to consumers. New drugs and complex medical devices must be proven safe and effective before reaching the market; new food additives must likewise be approved before use. Other products, such as x-ray machines and microwave ovens, must meet performance standards, while cosmetics and dietary supplements can generally be marketed without prior approval.
At the heart of every FDA medical product evaluation is a judgment about whether a new product's benefits to users outweigh its risks. No regulated product is entirely risk-free. The FDA will allow more risk when potential benefit is great, especially for products treating serious, life-threatening conditions. The agency reviews laboratory, animal, and human clinical testing conducted by companies (it does not develop or test products itself) for new human drugs and biologics (vaccines, blood products, biotechnology products, gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs. In recent years the FDA has streamlined its review process, bringing the average review time for an innovative new drug down to about 6 months, with some approved even faster.
