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The ipledge program rems (risk evaluation and mitigation strategy) the ipledge program rems is a safety program to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure. All isotretinoin manufacturers are part of the ipledge program, and health care providers and pharmacies must be registered with ipledge to be able to prescribe and dispense isotretinoin to. To get information about the ipledge program, you should talk to your doctor or visit the ipledge program website www.ipledgeprogram.com.
The ipledge program was put into place by a group formed by the companies that manufactured the drug at the time called the isotretinoin products manufacturing group (ipmg) under the direction of the food and drug administration. Regardless of gender identity, ipledge® requires anyone to register as a female of reproductive potential (frp) if they were assigned female at birth and have the potential for pregnancy The ipledge program is a set of steps all patients, doctors, and pharmacists must follow
The main goal is preventing pregnancy and birth defects, but both male patients and female patients must follow the ipledge program.
The ipledge rems is a safety program to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure The rems is required by the u.s Food and drug administration (fda) to ensure the benefits of isotretinoin outweigh its risks. Ipledge is a program designed to prevent fetal exposure to isotretinoin through strict guidelines and education for patients, prescribers, and pharmacies.
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