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  • Regulatory NewsRegulatory News

    Groups seek clarity on interchangeability in BsUFA III

    Industry groups and biosimilar manufacturers are seeking explicit guidance from the US Food and Drug Administration (FDA) on interchangeable biosimilar products. The comments were made to the agency as part of the reauthorization process for Biosimilar User Fee Act (BsUFA III) program.   The recommendations for improvements in the third iteration of FDA’s biosimilars review program were made as part of a public docket opened by FDA. The agency also recently held a ...
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    FDA: 2 years until SPL E-submission for REMS docs

    The US Food and Drug Administration (FDA) has issued final guidance on the electronic submission of documents related to the Risk Evaluation and Mitigation Strategies (REMS) using the Structured Product Labeling (SPL) format. The final guidance document starts the clock on compliance, with the new formatting requirements taking effect on 28 December 2022.   In the final guidance document, the FDA outlines how it will implement the requirements for e-submission of REM...
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    EMA updates advanced therapy guidelines for developers

    The European Medicines Agency (EMA) has updated its guidance to industry on the development of new medicines with genetically modified cells, including a special section on considerations for developing chimeric antigen receptor (CAR) T-cell therapies.   “It is recognised that this is an area under constant development and the guideline should be applied to any novel product as appropriate,” the EMA wrote in the new guideline.   The 36-page guideline provides rec...
  • Generics: FDA finalizes guidance on controlled correspondence

    The US Food and Drug Administration (FDA) has finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence process. The final guidance document, issued on 16 December, updates a draft that the agency released in 2017 (RELATED: “ FDA Drafts Guidance on Controlled Correspondence Under GDUFA II ,” Regulatory Focus 02 November 2017). The guidance incorporates changes that were part of the reaut...
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    WHO proposes update of GMPs for investigational products

    The World Health Organization is revising its guidance to industry on good manufacturing practices for investigational drug products, including new recommendations for quality risk management. The draft working document , which was released in November 2020, is open for public comment until 6 January 2021. The draft is expected to be revised and go through a second round of public comment before being presented to the WHO’s Expert Committee on Specifications for Pharmac...
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    FDA releases draft guidance for drug interaction studies with combined oral contraceptives

    The US Food and Drug Administration (FDA) has issued draft guidance for industry on performing clinical studies to look at the potential interactions between an investigational drug and combined oral contraceptives.   Interactions with other therapies can impact the efficacy and safety of combined oral contraceptives by affecting the enzymes involved in metabolizing progestins and estrogens. “For example, decreased progestin concentrations can lead to unintended pregna...
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    Experts propose changes to FDA’s Accelerated Approval Program

    A new white paper from the Friends of Cancer Research offers a blueprint for reimagining the US Food and Drug Administration (FDA) Accelerated Approval Program for drugs and biologics that treat serious and life-threatening illnesses. The white paper , released during the group’s annual meeting, recommends explicitly adding a more comprehensive risk-benefit assessment to the surrogate endpoints currently used as the basis for approval, a framework that would move the U...
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    FDA offers strategies to streamline schizophrenia drug trials

    Shortening the length of clinical trials and simplifying the symptom scale are two strategies that could help make schizophrenia drug trials less costly and more efficient, according to study findings from scientists at the U.S. Food and Drug Administration (FDA).   Schizophrenia drug developers face several obstacles when evaluating treatments, including high patient dropout rates in trials, modest treatment effects, high placebo response, and uncertainty about which ...
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    Novel vaccines typically take 8 years of clinical development: Study

    As the U.S. Food and Drug Administration (FDA) prepares to evaluate the first of the COVID-19 vaccine candidates, a group of researchers found that the traditional evaluation of novel vaccines has taken about 12 months and, in most cases, was based on at least two pivotal efficacy trials. Those trials enrolled a median of about 5,000 patients who were followed for 6 months to determine safety, the researchers found. “Given the urgency of developing a COVID-19 vaccine...
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    FDA lays out strategies for promoting diversity in clinical trial enrollment

    The US Food and Drug Administration (FDA) is encouraging drug and biologics sponsors to broaden enrollment criteria and to avoid unnecessarily excluding participants in a final guidance document aimed at increasing the diversity of clinical trial participants.   “To further promote and protect public health, it is important that people who are in clinical trials represent the populations most likely to use the potential medical product,” FDA Commissioner Stephen M. Hah...
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    Makena indication may fall based on post-approval data

    The US Food and Drug Administration (FDA) is seeking to withdraw the approval of the only drug indicated to prevent recurrent preterm birth, based on a post-approval study showing a lack of efficacy.   Makena (hydroxyprogesterone caproate injection) was originally granted accelerated approval in 2001 and remains on the market. Makena’s manufacturer, AMAG Pharmaceuticals, has requested a public hearing to explore the issue. It is up to the FDA commissioner whether to gr...
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    FDA seeks comment on plan to increase REMS transparency

    The US Food and Drug Administration (FDA) is seeking to be more transparent about its Risk Evaluation and Mitigation Strategy (REMS) program.   The agency is seeking public comment on its plan to publish its evaluations of how individual drug and biologics sponsors are doing on the implementation of REMS programs.   REMS is a long-standing drug safety program that allows the FDA to require manufacturers to implement specific safety measures that go beyond drug labe...