On this Page:
Approval information by product type
Drugs
Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes)
Latest drug approvals (listed by date)
AIDS drugs under President’s Emergency Plan for AIDS Relief
Archives
Biological Products
Vaccines, tissue, blood, and other products derived from living sources
Biological product information page
Medical Devices
Instruments or products used for treating or diagnosing disease (such as thermometers, artificial hearts, and home pregnancy test kits)
Latest medical device approvals
Archives
Animal Drugs
FDA Approved Animal Drug Products (Green Book)
Food Additives
Food and color additive information
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.
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