Definition: This task is about reading the given passage and construct a question about the information present in the passage. Construct a question in such a way that (i) it is unambiguous, (ii) it is answerable from the passage, (iii) its answer is unique (iv) its answer is a continuous text span from the paragraph. Avoid creating questions that (i) can be answered correctly without actually understanding the paragraph and (ii) uses same words or phrases given in the passage.
Input: 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.
Output:
The safety and efficacy of new drugs must be approved by what organization in the US?