The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the healthcare products sector.
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While new approach methodologies offer a path to reduced reliance on animal testing, experts say global regulators need to agree on their use to give sponsors predictability and regulatory assurance.
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Pharmaceutical industry groups largely support FDA's proposed rule on distributed manufacturing but are seeking clarification on how the proposed model would function and specific changes they say would make it easier to implement.
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Consumer health groups urged FDA to allocate more resources for testing generic drugs and to implement stricter metrics for postmarket safety reporting at a public meeting on Thursday discussing the reauthorization of the Generic Drug User Fee Amendments.
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Officials from FDA, UK Medicines and Healthcare products Regulatory Agency, and other European regulators said that successful meetings with sponsor involved transparency, open collaboration, listening, and having sufficient data to answer questions.
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Regulators and industry experts stressed the need for regulatory harmonization around artificial intelligence to ensure the technology is used responsibly in drug development during a panel discussion at RAPS Convergence 2026.
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FDA plans to replace terminology related to animal testing with broader terms, such as “nonclinical tests” and “nonclinical studies” throughout its regulations to facilitate the use of nonanimal methods in drug development.
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Officials from FDA reaffirmed the administration's priorities in the proposed commitment letter for the Prescription Drug User Fee Act program during a public meeting on Wednesday.
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Officials from the European Commission and European Medicines Agency touted key reforms presented in the proposal to overhaul the bloc’s pharmaceutical legislative framework during a panel discussion at RAPS Convergence 2026.
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When former FDA Commissioner Robert Califf was a medical student in the mid-1970s, he had an opportunity to work with his mentor on one of the first patient databases.
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A panel of experts representing the European Commission, industry and notified bodies reviewed the state discussed the current state of play amid proposed reforms to the EU Medical Device Regulation and In Vitro Diagnostics Regulation at RAPS Convergence.
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Officials from FDA, the European Medicines Agency, and industry representatives offered advice for considering and developing clinical trials that achieve representative enrollment of patient populations.
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Experts in medical device and pharmaceutical regulatory affairs discussed how the field has evolved over the last five decades.
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We're so glad to be back at #RAPSConvergence 💙.
Three days of learning, connecting, and putting regulatory affairs at the center of our world.
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FDA officials said the agency is open to novel, “innovative approaches” to the clinical development of psychedelic drugs in light of the worsening mental health crisis in the US.
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FDA has announced the permanent appointment of four top officials to lead the agency's drug, biologics, and tobacco centers, as well as a deputy commissioner for technology and artificial intelligence.
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The European Medicines Agency has published a guidance on how companies submitting marketing authorization applications should provide electronic product information for products under the EU's centrally authorized review process.
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Industry stakeholders want the FDA to expand the scope of its recent draft guidance on the types of scientifically valid prior knowledge sponsors may consider when developing gene therapies that involve genome editing.
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The European Medicines Agency has launched a voluntary data submission pilot to allow drug developers to share data generated by new approach methodologies.
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FDA has published a draft guidance on how to design trials and analyze data from studies examining the pharmacokinetics and pharmacodynamics of drugs in patients with hepatic impairment.
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