Poly Pred FDA Prescribing Information, Side Effects and Uses

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Thank You ray and good morning everybody so I'm going to be discussing Cedars review of the prescribing information so FDA approves several different types of labeling as lovey mentioned earlier there's the carton and container labeling there's medication guides there's a patient package inserts I'm going to be focusing on the prescribing information which used to be called the package and serve actually and the print the actually prescribing information is written for and directed to healthcare providers and not patients there are specific types of labeling such as medication guides and patient package inserts that are directed to patients but the prescribing information really is just for the healthcare provider many of the principles that we'll be discussing about how we review labeling can also be used by applicants and developing labeling so our learning objectives for this session are to understand the regular regulatory requirements for the prescribing information the roles and