Skip to main content

Risk Evaluation and Mitigation Strategies Guidance for Pharmaceutics and Biologics

BayBiotech.NET




FDA has posted draft guidance for Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications on its website. The draft guidance has been posted in September 2009 and is open for comments and feedbacks from all that may have an interest
in the subject.
In a nutshell, the guidance authorizes FDA to require the applicants of NDA (new drug applications), ANDAs (abbreviated new drug applications), and biologics license applications (BLAs) to submit a proposed
Risk Evaluation and Mitigation Strategies (REMS) within 180 days once notified by FDA and may come to the applicant, if FDA becomes aware that such a strategy might be necessary to ensure that the benefits of the drug outweigh the risks of the drug in question.
Before September 2007, when the Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed, FDA used to approve a small number of drug and biological products with risk minimization action plans (RiskMAPs) that was considered to be a strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits.
RiskMAPs were developed for products that had risks that required additional risk management strategies beyond describing the risks and benefits of the product in labeling and performing required safety reporting.

Since now FDAAA has given FDA the authority to require REMS when necessary to ensure that the benefits of a drug outweigh the risks, if FDA determines even after approval of the product, that a REMS is necessary even if the drug had satisfied the RiskMAP requirements, the involved party may have to submit REMS plans if notified by the agency.
Although, there are number of overlaps that eventually will be carried over from RiskMAPs to REMS,
to further understand the details of the expected content of REMS submission, follow the link provided here:


http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf


Comments

Popular posts from this blog

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...