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    ICH announces sign-off on good clinical practices guideline

    The International Council for Harmonization (ICH) recently announced that the E8(R1) guideline on general considerations for clinical studies had reached Step 4 and is awaiting sign-off by regulators. The widely anticipated guideline modernizes the design, conduct and reporting of clinical trials by adopting quality by design principles. The guideline incorporates “current concepts achieving fit-for-purpose data quality.”   ICH announced that “the modernisation of IC...
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    September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more

    Feature articles during September focused on diversity in regulatory affairs, challenges in conducting medical device clinical trials in Europe, clinical trial regulation and laws in China, and risk management in working with third-party distributors.   Equity in action, diversity, and resilience In Fall 2020, representatives from Pfizer Global Regulatory Affairs (GRA) and the Howard University College of Pharmacy (HUCOP) initiated discussions about creating a care...
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    Euro Roundup: PRAC starts reviewing risk of tumors linked to women’s health products

    The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started reviewing the risk of tumors linked to women’s health products that contain nomegestrol or chlormadinone. PRAC opened the review in response to cases of non-malignant tumors of the brain and spinal cord.   Nomegestrol or chlormadinone are used in products that treat gynecological disorders, such as uterine bleeding, and as hormone replacement therapies or contraceptives...
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    Recon: Pfizer, BioNTech request vaccine EUA for children 5-11; Moderna plans African vaccine manufacturing site

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer vaccine for children may be ready by Thanksgiving -White House adviser ( Reuters ) Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11 ( Reuters ) ( WSJ ) ( Politico ) Tensions grow between Moderna, White House over vaccine production ( Politico ) Moderna Wants Fed. Cir. Help to Avoid Covid Vaccine Patent Suits ( Bloomberg ) Biden c...
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    FDA revises guidance on hospital, health system compounding

    Five years after issuing draft guidance detailing its enforcement policy toward hospitals and health system pharmacy compounding under section 503A of the Federal Food, Drug, and Cosmetic Act , the US Food and Drug Administration (FDA) has revised its approach to give more flexibility to hospitals and health systems and to address compounded drugs that are essentially copies of commercially available drugs.   "We understand that compounded drugs can serve an important...
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    New MDCG guidance shows how devices fit into MDR’s classification rules

    The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.   Under the MDR , which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest.  Annex VIII of the...
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    RAPS AnnouncementsRAPS Announcements

    RAPS updates website with new look, more intuitive navigation

    RAPS has redesigned its website, updating it with new navigation and features to help make it easier to find exactly what you are looking for. New homepage The first thing you will likely see when visiting RAPS.org is the refreshed, new-look homepage. We have added five prominent navigation blocks right on the homepage, linking you to RAPS’ most sought after content—news, membership information, education offerings, certification information and resources. We also ha...
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    FDA Approvals Roundup: Livmarli and Tecartus

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Livmarli approved for cholestatic pruritus in children with Alagille syndrome Mirum’s Livmarli (maralixibat oral solution) has been approved for treating cholestatic pruritus in patients aged 1 year or older who have Alagille syndrome (ALGS).   ALGS is a rare genetic disorder caused by abnormalities in bile ducts that can lead to progressive ...
  • ReconRecon

    Recon: Pfizer, Voyager sign $630M gene therapy deal; WHO backs malaria vaccine for children in Africa

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Polarean Imaging says FDA rejects new drug application, shares slump ( Reuters ) FDA center directors on lessons from the EUA pathway: Flexibility serves us well ( Endpoints ) Troubled Voyager’s gene therapy relaunch gets a boost with $630M Pfizer deal ( Endpoints ) FDA offers support for Takeda's potential cytomegalovirus drug ahead of adcomm ( Endpoints ) A...
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    New guide to clinical trial lay summaries available for EU sponsors

    The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.   The EC’s Clinical Trials Expert Group (CTEG) adopted the guidelines in July 2021; the 85-page document walks users through the lay summary (LS) process from the planning and scoping stage, through the develop...
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    FDA finalizes long delayed de novo classification rule

    The US Food and Drug Administration (FDA) on Monday issued a final rule setting requirements for the medical device de novo classification process, codifying procedures and criteria for new types of medical devices to be authorized as Class I or Class II devices.   "These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also i...
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    Asia-Pacific Roundup: China’s NMPA applies for pre-accession to PIC/S

    China’s National Medical Products Administration (NMPA) has applied for “pre-accession” to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The voluntary step is intended to identify gaps between PIC/S membership requirements and the system used by the regulatory agency.   PIC/S held a bilateral meeting with NMPA late in 2019 to discuss issues raised by the Chinese drug regulatory agency in relation to a possible future application or pre-application. Almos...