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Biotechnology
Regulations
Chapter 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 crops
The EPA or
Environmental
Protection Agency is
a US government
agency that
regulates genetically
modi...
3. Regulates Water Quality
The EPA or
Environmental
Protection Agency is
a US government
agency that regulates
water quali...
4. Environmental Release
The EPA or Environmental
Protection Agency, The FDA
or Food and Drug Agency,
and USDA or US Depar...
5. How do patents regulate drugs?
Patents regulates
drugs and devices
because a product
released must be
functional, usabl...
6. New streamlined processes in
European drug market.
New streamlined
approval processes in
Europe have affected
their dru...
7. Greatest number of patent applicants in
Cancer Therapy.
Europe has the most
applicants of Cancer
Therapy applicants
bec...
8.Fluvirin incident and FDA
Firms should evaluate
every aspect of
production; including
people, procedures,
equipment, mat...
9. Patenting an EST
Patents products should
be nonobvious and have
utility, EST’s are not
products and only
function to id...
10. Drugs at EU and USA
The EMEA has no
knowledge of drug
product until it is
submitted for approval;
therefore a drug wil...
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Biotechnology regulations ch. 12

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Biotechnology regulations ch. 12

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Biotechnology regulations ch. 12

  1. 1. Biotechnology Regulations Chapter 12: Essence Perry
  2. 2. 1. Regulates Food Additives The FDA or Food and Drug Agency is a U.S agency that regulates food additives.
  3. 3. 2. Regulates GM crops The EPA or Environmental Protection Agency is a US government agency that regulates genetically modified crops.
  4. 4. 3. Regulates Water Quality The EPA or Environmental Protection Agency is a US government agency that regulates water quality.
  5. 5. 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.
  6. 6. 5. How do patents regulate drugs? Patents regulates drugs and devices because a product released must be functional, usable, and have no observable malfunctions.
  7. 7. 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.
  8. 8. 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.
  9. 9. 8.Fluvirin incident and FDA Firms should evaluate every aspect of production; including people, procedures, equipment, materials, record keeping, audits, and training.
  10. 10. 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.
  11. 11. 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.

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