Question: The food safety system of the agency that has the authority to decide if a drug is marketed otc or prescription is known as?

Knowledge 1: Over-the-counter drug
A similar regulation applies to some forms of emergency contraception. The FDA considers them to be OTC substances for females 17 or over but prescription drugs for younger women. To enforce the restriction and to provide counseling and education on proper use, an agreement between the manufacturer and the FDA requires the drugs are stored behind the pharmacy counter. Women may obtain the medication without a prescription after providing proof of age to pharmacy staff and receiving any necessary patient education. [SEP] Knowledge 2: Pharmaceutical industry
In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted.
Knowledge 1: Over-the-counter drug
A similar regulation applies to some forms of emergency contraception. The FDA considers them to be OTC substances for females 17 or over but prescription drugs for younger women. To enforce the restriction and to provide counseling and education on proper use, an agreement between the manufacturer and the FDA requires the drugs are stored behind the pharmacy counter. Women may obtain the medication without a prescription after providing proof of age to pharmacy staff and receiving any necessary patient education. [SEP] Knowledge 2: FDA Food Safety Modernization Act
The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authorities to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.
Knowledge 1: Pharmaceutical industry
In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted. [SEP] Knowledge 2: FDA Food Safety Modernization Act
The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authorities to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.

Answer: Food Safety Modernization Act (FSMA)