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Use of a Drug Master File for
Shared System REMS SubmissionsGuidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
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How to fill out use of a drug
How to fill out use of a drug
01
Read the drug's prescription label and follow the instructions provided by your healthcare professional.
02
Make sure your hands are clean before handling the drug.
03
Use the provided measuring device such as a dropper, syringe, or cup to measure the correct dosage of the drug.
04
If the drug needs to be taken with food, follow the instructions on whether it should be taken before, after, or during a meal.
05
Swallow the drug with a glass of water unless instructed otherwise.
06
If the drug needs to be taken at specific times of the day, set reminders to ensure you take it on time.
07
Do not skip any doses unless instructed by your healthcare professional.
08
Store the drug in a cool, dry place and away from direct sunlight.
09
If you experience any side effects or have any concerns about the drug, contact your healthcare professional for guidance.
10
Do not share the drug with others even if they have the same condition, as it may not be suitable for them.
Who needs use of a drug?
01
The use of a drug is dependent on the specific condition it is intended to treat or manage.
02
Individuals who have been diagnosed with the corresponding medical condition for which the drug is indicated may need to use it.
03
It is important to consult with a healthcare professional to determine if the drug is appropriate and necessary based on an individual's medical history, current medications, and overall health status.
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What is use of a drug?
The use of a drug refers to consuming a medication for its intended medical purpose.
Who is required to file use of a drug?
Healthcare providers or individuals prescribed the drug may be required to report the use of a drug.
How to fill out use of a drug?
To fill out use of a drug, one must provide details such as the name of the drug, dosage, frequency of use, and any side effects experienced.
What is the purpose of use of a drug?
The purpose of reporting the use of a drug is to track the effectiveness and safety of medications in patients.
What information must be reported on use of a drug?
Information such as the name of the drug, dosage, frequency of use, duration of use, and any side effects must be reported on use of a drug.
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