• Regulatory NewsRegulatory News

    Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines

    The European Federation of Pharmaceutical Industries and Associations (EFPIA) is calling for greater harmonization of genetically modified organism (GMO) procedures for investigational medicinal products, saying the complex process has the potential to slow the initiation of clinical trials for advanced and cellular therapies.   In a perspective article in Cell & Gene Therapy Insights and a related press release, EFPIA said the current system is more restrictive than...
  • ReconRecon

    Recon: EU says Russia delayed EMA Sputnik V inspections; FDA approves ChemoCentryx's Tavneos for rare autoimmune disease

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's biomedical research agency dropped from social spending bill ( Politico ) ChemoCentryx's drug gets US FDA nod for treating rare autoimmune disease ( Reuters ) FDA's antimicrobial adcomm unanimously backs Takeda's drug for post-transplant cytomegalovirus ( Endpoints ) Newly revealed texts from ex-FDA leader Stephen Hahn offer behind-the-scene glimpse in...
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    FDA reclassifies surgical staplers, staples after review links devices to injuries and deaths

    The US Food and Drug Administration (FDA) on Thursday reclassified surgical staplers and staples for internal use from Class I (general controls) to the more stringent Class II (special controls) after a 2019 review of adverse events linked the devices to reports of hundreds of deaths and thousands of injuries.   With the final reclassification order in place, surgical staplers for internal use must now undergo premarket review and will be subject to special controls b...
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    FDA recognizes Memorial Sloan Kettering tumor variant database

    The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant Database listing. The move opens the door for developers of tumor profiling tests to use the database to support clinical validity claims in regulatory submissions.   A portion of Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OnkoKB) received the recognition under FDA’s database recognition program. ...
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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...
  • Feature ArticlesFeature Articles

    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...
  • RoundupsRoundups

    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...
  • ReconRecon

    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...
  • RoundupsRoundups

    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 ...