...effective treatment may not be available domestically either through commercial or clinical means ; 2) there is no known commercialization or promotion to...involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk) and 4) the individual seeking to...

...are not advised to exercise their discretion when Page 5 - The Honorable Thomas J. Bliley there is known commercialization or promotion to persons residing...involved in the distribution of the product at issue. In addition, the guidance makes clear that although FDA may use discretion to allow admission of certain...

...are not advised to exercise their discretion when Page 5 - The Honorable Thomas J. Blil« there is known commercialization or promotion to persons residing in the US by those involved in the distribution ol the product at issue. In addition, the guidance makes clear that although FDA may use discretion...

...real quick— the other two points is there are is no known commercialization or promotion to a person residing in the US by those involved in the distribution...unreasonable risk, and the individual seeking to import those products affirms in writing that it is for the patient's own use generally not more than 3 months...

...real quick— the other two points is there are is no known commercialization or promotion to a person residing in the US by those involved in the distribution...unreasonable risk, and the individual seeking to import those products affirms in writing that it is for the patient's own use generally not more than 3 months...

...effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to...involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to...

...effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to...involved in the distribution of the product at issue; 3) the product a considered not to represent an unreasonable risk; and 4) the individual seeking to...

...effective treatment may not be available domestically either through commercial or clinical means; b) mere is no known commercialization or promotion to persons...involved in the distribution of the product at issue; c) the product is considered opt to represent an unreasonable risk; and d) the individual seeking to...

...treat a serious condition for which effective treatment may not be available domestically. Secondly, there is no known commercialization or promotion to persons residing in the US by those importing the drug. Thirdly, the unapproved product is considered not to represent and unreasonable...

...effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to...involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to...