Compared to conventional production methods, but there are also considerable regulatory challenges that must be met. There are currently about 30 protein-based medicines on the market, and close to 100 in late-stage human trials. Consequently, companies are motivated to provide a wider range of options for production of proteins used in these treatments. Biopharmaceuticals are medical drugs (see pharmacology) produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source. [1] There is much debate over the practicality of using plants to produce proteins?" In the United States, the Food and Drug Administration (FDA) exerts strict control over the commercial distribution of a pharmaceutical product, including biopharmaceuticals. Approval can require several years of clinical trials, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks. Pharming in plants The manufacture of the drug can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug must satisfy the "current Good Manufacturing Practices" regulations of the FDA. They are typically manufactured in a clean room environment with set standards for the amount of.