Exact(3)
Factors such as race, age, preoperative indications, route of hysterectomy, oophorectomy, and hormone replacement therapy did not affect outcome scores.
Aspects of use examined included indications, route, dose, dilution, diluent and compatibility.
Although the scope of content of the counselling recommended in each guideline varies, all agree on providing the following information: name and description of the medicine, indications, route of administration, dose and dosage form, directions for use, duration of therapy, special directions, precautions, side effects, and contraindications [ 3, 7].
Similar(57)
If you look closely at the tricky language of the sentence you will see that changes to biologics that result in new indications, routes, dosing schedules, delivery systems, strengths, etc., are ineligible for another 12- year exclusivity period under the Eshoo approach only if they come about without a modification to the structure of the product.
There is in fact an 'anti-evergreening' clause which explicitly provides no new exclusivity period would be granted for "a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength".
The clause Representative Eshoo refers to does appear on its face to exclude changes that result in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength from being eligible for a new 12-year exclusivity period.
We considered documents as relevant to off-label drug use, if they referred to any human drug outside the approval purposes, in terms of different dose, indication, route of application or for another age group.
No additional period of exclusivity will be granted to a previously licensed biologic product when subsequent applications are made for a new indication, route of administration, dosage form, or dosing strength.
Despite a lack of evidence showing improved clinical outcomes with robotic-assisted hysterectomy over other minimally invasive routes for benign indications, this route has increased in popularity over the last decade.
For each of these drugs, we used the SPC information available from the Claude Bernard database, including, in particular, the paragraphs concerning composition, pharmacodynamics, therapeutic indications, dosage, route of administration, technical and regulatory data (approval date, price, etc).
See, e.g., 21 CFR § 801.109 (requiring labels to include such information as indications, effects, routes, methods, frequency and duration of administration, relevant hazards, contraindications, side effects, and precautions).
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