Biotechnology RegulationsChapter 12: Essence Perry

1. Regulates Food Additives The FDA or Food and Drug Agency is a U.S agency that regulates food additives.

2. Regulates GM cropsThe EPA or Environmental Protection Agency is a US government agency that regulates genetically modified crops.

3. Regulates Water Quality The EPA or Environmental Protection Agency is a US government agency that regulates water quality.

4. Environmental Release The EPA or Environmental Protection Agency, The FDA or Food and Drug Agency, and USDA or US Department of Agriculture are US government agencies that regulate environmental releases of genetically engineered organisms.

5. How do patents regulate drugs?

Patents regulates drugs and devices because a product released must be functional, usable, and have no observable malfunctions.

6. New streamlined processes in European drug market.

New streamlined approval processes in Europe have affected their drug market because approvals that took four year now take one.

7. Greatest number of patent applicants in Cancer Therapy.

Europe has the most applicants of Cancer Therapy applicants because every step of the purification process is usually patented.

8.Fluvirin incident and FDA Firms should evaluate every aspect of production; including people, procedures, equipment, materials, record keeping, audits, and training.

9. Patenting an EST Patents products should be nonobvious and have utility, EST’s are not products and only function to identify location, they do not qualify as patentable.

10. Drugs at EU and USA The EMEA has no knowledge of drug product until it is submitted for approval; therefore a drug will take a shorter time for approval.