INOPP Forum
FDA REMS
Quote from VigiServe Admin on December 5, 2020, 10:53 AMA Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviours and actions that support the safe use of that medication. While all medications have labelling that informs health care stakeholders about medication risks, only a few medications require a REMS.
REMS was previously known as RiskMAP
What is the purpose of a Risk Evaluation and Mitigation Strategy (REMS)?
REMS is designed to help reduce the occurrence or severity of a particular serious adverse event. They help support a drug’s safe use as described in the product’s FDA-approved prescribing information. Once FDA determines a REMS is necessary for a drug, pharmaceutical manufacturers must develop, implement, and assess the specific REMS for their drug product. It is important for health care professionals, patients, and all others whom REMS affect to be aware that REMS can provide safe access for patients to certain drugs with serious risks that may otherwise not be approved and available on the market.
Are REMS permanent?
FDA may release a REMS or remove certain components of a REMS, if, after reviewing of REMS assessments or other information, we determine that the extra measures in a REMS are no longer necessary to ensure a medication’s benefits outweigh its risks.
Approved Risk Evaluation and Mitigation Strategies (REMS) in the US - LINK
Can Generic products require REMS?
The law requires that when a drug has a REMS, any generics for these drugs must also have a REMS. Sometimes, the brand name manufacturer and the generic version’s manufacturer jointly develop and implement a REMS (i.e., a shared system REMS). At other times, the brand name drug and the generic each have different REMS, but both have the same goal(s), the same requirements, and comparable processes in place to meet those goals and requirements.
Development of a Shared System REMS
A shared system REMS encompasses multiple prescription drug products and is developed and implemented jointly by two or more applicants.
A REMS that includes more than one product but only a single applicant is not considered a shared system REMS. A shared system REMS can be a program shared by a drug that is the subject of an abbreviated new drug application (ANDA) and the listed drug, as required in section 505-1(i)(1)(B) of the FD&C Act. It can also involve multiple NDAs or ANDAs, submitted under section 505(b)(1), (b)(2), or (j) of the FD&C Act, or multiple biologics license applications (BLAs), submitted under section 351(a) or (k) of the PHS Act, that form a shared system voluntarily.
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviours and actions that support the safe use of that medication. While all medications have labelling that informs health care stakeholders about medication risks, only a few medications require a REMS.
REMS was previously known as RiskMAP
What is the purpose of a Risk Evaluation and Mitigation Strategy (REMS)?
REMS is designed to help reduce the occurrence or severity of a particular serious adverse event. They help support a drug’s safe use as described in the product’s FDA-approved prescribing information. Once FDA determines a REMS is necessary for a drug, pharmaceutical manufacturers must develop, implement, and assess the specific REMS for their drug product. It is important for health care professionals, patients, and all others whom REMS affect to be aware that REMS can provide safe access for patients to certain drugs with serious risks that may otherwise not be approved and available on the market.
Are REMS permanent?
FDA may release a REMS or remove certain components of a REMS, if, after reviewing of REMS assessments or other information, we determine that the extra measures in a REMS are no longer necessary to ensure a medication’s benefits outweigh its risks.
Approved Risk Evaluation and Mitigation Strategies (REMS) in the US - LINK
Can Generic products require REMS?
The law requires that when a drug has a REMS, any generics for these drugs must also have a REMS. Sometimes, the brand name manufacturer and the generic version’s manufacturer jointly develop and implement a REMS (i.e., a shared system REMS). At other times, the brand name drug and the generic each have different REMS, but both have the same goal(s), the same requirements, and comparable processes in place to meet those goals and requirements.
Development of a Shared System REMS
A shared system REMS encompasses multiple prescription drug products and is developed and implemented jointly by two or more applicants.
A REMS that includes more than one product but only a single applicant is not considered a shared system REMS. A shared system REMS can be a program shared by a drug that is the subject of an abbreviated new drug application (ANDA) and the listed drug, as required in section 505-1(i)(1)(B) of the FD&C Act. It can also involve multiple NDAs or ANDAs, submitted under section 505(b)(1), (b)(2), or (j) of the FD&C Act, or multiple biologics license applications (BLAs), submitted under section 351(a) or (k) of the PHS Act, that form a shared system voluntarily.
Uploaded files:
- You need to login to have access to uploads.
Quote from VigiServe Admin on December 23, 2020, 3:21 PMProviding Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Guidance for Industry - December 2020
Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Guidance for Industry - December 2020
Uploaded files:- You need to login to have access to uploads.