Global Life Scienceshttps://www.sidley.com/ja/rss/global-life-sciencesja60{AA1A85DF-D46D-4AA2-86E5-3A6B34E51B78}https://www.sidley.com/ja/insights/newsupdates/2026/04/most-favored-nation-drug-pricing-policy-executive-actions-manufacturer-agreementsSidley UpdatesMost-Favored-Nation Drug Pricing Policy: Executive Actions, Manufacturer Agreements, and Growing Congressional ScrutinyWed, 22 Apr 2026 05:00:00 Z{BB6EFD8B-217C-4D35-BC47-69283CB855BB}https://www.sidley.com/ja/insights/newsupdates/2026/04/us-fda-issues-first-drug-supply-chain-security-act-warning-letter-targeting-a-dispenserSidley UpdatesU.S. FDA Issues First Drug Supply Chain Security Act Warning Letter Targeting a Dispenser, Signaling Expanded Enforcement FocusWed, 15 Apr 2026 05:00:00 Z{012B7DD6-9CE4-4C25-9BF7-C5C156F32FA4}https://www.sidley.com/ja/insights/newsupdates/2026/04/white-house-and-doj-announce-sweeping-new-anti-fraud-initiativesSidley UpdatesWhite House and DOJ Announce Sweeping New Anti-Fraud InitiativesFri, 10 Apr 2026 05:00:00 Z{DA5468F3-BA87-44F6-BB29-6C79D1EFBECB}https://www.sidley.com/ja/insights/newsupdates/2026/03/market-access-another-favorable-medical-products-advisory-opinion-from-hhsSidley Updates#Market Access: Another Favorable Medical Products Advisory Opinion from HHS-OIG Signals New FlexibilitiesThu, 19 Mar 2026 05:00:00 Z{F0C3CAF2-12DD-4867-AAFE-0690BBE93F28}https://www.sidley.com/ja/insights/newsupdates/2026/02/direct-to-consumer-prescription-drug-platforms-new-government-guidance-and-comment-opportunitySidley UpdatesDirect-to-Consumer Prescription Drug Platforms: New Government Guidance and Comment OpportunityTue, 24 Feb 2026 06:00:00 Z{41D430B5-2A58-4250-B4B1-E7D35D2F624A}https://www.sidley.com/ja/insights/newsupdates/2026/02/veterinary-biologics-and-biosimilars-routes-to-approval-and-commercialization-in-the-us-eu-and-ukSidley UpdatesVeterinary Biologics and Biosimilars: Routes to Approval and Commercialization in the U.S., EU, and UKFri, 20 Feb 2026 06:00:00 Z{921CA9D9-9ABB-490B-8F6B-5264836A66D2}https://www.sidley.com/ja/insights/newsupdates/2026/02/congress-passes-significant-federal-pharmacy-benefit-manager-reform-impacting-pharmaceutical-marketSidley UpdatesCongress Passes Significant Federal Pharmacy Benefit Manager Reform Impacting Pharmaceutical Market AccessWed, 18 Feb 2026 06:00:00 Z{41E7055D-B7A1-4411-856C-CCB7D4ED4406}https://www.sidley.com/ja/insights/newsupdates/2026/02/oig-releases-long-awaited-medicare-advantage-compliance-program-guidanceSidley UpdatesOIG Releases Long-Awaited Medicare Advantage Compliance Program GuidanceTue, 10 Feb 2026 06:00:00 Z{4FD37680-D6A6-4C4E-87FB-0EB723B27090}https://www.sidley.com/ja/insights/newsupdates/2026/01/medical-products-market-access-favorable-advisory-opinion-reaffirms-discounting-flexibilitiesSidley UpdatesMedical Products Market Access: Favorable Advisory Opinion Reaffirms Discounting FlexibilitiesWed, 21 Jan 2026 06:00:00 Z{93EB3131-3AC6-4649-925E-BCD084C1C126}https://www.sidley.com/ja/insights/newsupdates/2026/01/impact-of-fda-warning-letters-in-europe-practical-considerations-for-industrySidley UpdatesImpact of U.S. FDA Warning Letters in Europe: Practical Considerations for IndustryMon, 12 Jan 2026 06:00:00 Z{98235C28-1F65-4421-A2DB-3CB95D7832A0}https://www.sidley.com/ja/insights/newsupdates/2026/01/top-10-areas-we-watching-for-2026Sidley UpdatesTop 10 FDA Areas We Are Watching For 2026As 2026 begins, there is much to look forward to as companies and investors in the life sciences and medtech industries navigate a profoundly changing regulatory environment at FDA. With 2025 witnessing generational changes at FDA, we’re keeping an eye on opportunities and challenges for the year to come.Mon, 12 Jan 2026 06:00:00 Z{490F99D9-E289-43C4-A7D5-4630D04D2251}https://www.sidley.com/ja/insights/newsupdates/2026/01/drugpricing-more-average-sales-price-proposals-and-new-comment-periodSidley Updates#DrugPricing: More Average Sales Price Proposals and New Comment PeriodTue, 06 Jan 2026 06:00:00 Z{F92E55B6-B943-42C1-A6F7-51F6FD93208D}https://www.sidley.com/ja/insights/newsupdates/2025/12/eu-biotech-act-eu-proposes-first-set-of-rules-to-facilitate-biopharmaceutical-competitivenessSidley UpdatesEU Biotech Act: EU Proposes First Set of Rules to Facilitate Biopharmaceutical CompetitivenessThu, 18 Dec 2025 06:00:00 Z{342BEDB1-41BF-4BFC-B5F7-720BB6C3BAA3}https://www.sidley.com/ja/insights/newsupdates/2025/12/eu-pharma-package---sharp-new-tools-with-limited-protectionsSidley UpdatesEU Pharma Package: Sharp New Tools With Limited ProtectionsLast week, concluding a seven-year process, the Council of the European Union and the European Parliament agreed on the EU Pharma Package consisting of a new Pharmaceutical Directive and Pharmaceutical Regulation. The Package introduces pivotal changes to the EU pharmaceutical legislation, most significantly the introduction of new launch and supply obligations with only limited safeguards and a reduction and modulation of regulatory data protection and market protection, requiring companies to re-think their pipeline strategies. The provisional agreement now needs to be endorsed by both the Council and the Parliament before being formally adopted and entering into force upon publication in the Official Journal of the European Union. The final text is expected to become available in the coming weeks.Thu, 18 Dec 2025 06:00:00 Z{D92DA836-023B-4C42-B155-43A76622D984}https://www.sidley.com/ja/insights/newsupdates/2025/12/us-drug-pricing-year-in-review-reflections-on-2025-and-getting-ready-for-2026Sidley UpdatesU.S. Drug Pricing Year in Review: Reflections on 2025 and Getting Ready for 2026Thu, 11 Dec 2025 06:00:00 Z{80BB087E-FE40-4CAB-969D-7F1F33BA4490}https://www.sidley.com/ja/insights/newsupdates/2025/12/what-the-us-uk-drug-pricing-agreement-reveals-about-how-mfn-drug-policy-could-impact-the-uk-and-euSidley UpdatesWhat the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EUWed, 10 Dec 2025 06:00:00 Z{DB86E304-03FB-4EEB-BD07-617BE54EFB62}https://www.sidley.com/ja/insights/newsupdates/2025/12/eu-digital-omnibus-implications-for-medtech-companiesSidley UpdatesEU Digital Omnibus Implications for MedTech CompaniesTue, 09 Dec 2025 06:00:00 Z{95E5F542-933E-4EC4-BFF5-0B1DDD6B50C5}https://www.sidley.com/ja/insights/newsupdates/2025/12/us-fdas-adoption-of-ich-e6r3-good-clinical-practice-key-takeaways-for-sponsors-and-investigatorsSidley UpdatesU.S. FDA's Adoption of ICH E6(R3) Good Clinical Practice: Key Takeaways for Sponsors and InvestigatorsThu, 04 Dec 2025 06:00:00 Z{1FDB0166-E339-4D75-8C0B-6785F877CC64}https://www.sidley.com/ja/insights/newsupdates/2025/12/medicare-payment-policy-final-rule-for-outpatient-setting-addresses-radiopharmaceuticalsSidley UpdatesMedicare Payment Policy Final Rule for Outpatient Setting Addresses Radiopharmaceuticals, Skin Substitutes, and 340B Program Key TopicsTue, 02 Dec 2025 06:00:00 Z{475B293B-BC7A-4153-B69C-75EB1917ABED}https://www.sidley.com/ja/insights/newsupdates/2025/11/us-fda-and-cms-actions-on-generative-ai-enabled-mental-health-devices-yield-insights-across-aiSidley UpdatesU.S. FDA and CMS Actions on Generative AI-Enabled Mental Health Devices Yield Insights Across AI Product DevelopmentWed, 12 Nov 2025 06:00:00 Z{8A344660-AAA7-495D-9E49-06F7060CE33D}https://www.sidley.com/ja/insights/newsupdates/2025/11/cms-announces-voluntary-most-favored-nation-pricing-in-medicaid-through-the-generous-modelSidley UpdatesCMS Announces Voluntary Most-Favored-Nation Pricing in Medicaid Through the GENEROUS ModelTue, 11 Nov 2025 06:00:00 Z{44C55643-195A-43D1-BB34-E39A63E31A15}https://www.sidley.com/ja/insights/newsupdates/2025/11/cms-finalizes-key-medicare-reimbursement-policies-for-telehealth-chronic-disease-and-digital-healthSidley UpdatesCMS Finalizes Key Medicare Reimbursement Policies for Telehealth, Chronic Disease, and Digital HealthTue, 04 Nov 2025 06:00:00 Z{00A929E4-7CF6-4098-9C1B-9EF1F16E4FC7}https://www.sidley.com/ja/insights/newsupdates/2025/10/major-changes-to-us-government-pricing-requirements-finalized-with-some-wins-for-pharma-and-biotechSidley UpdatesMajor Changes to U.S. Government Pricing Requirements Finalized, With Some Wins for Pharma and BiotechMon, 03 Nov 2025 06:00:00 Z{19637343-5B32-4BB5-B697-0CE992600807}https://www.sidley.com/ja/insights/newsupdates/2025/10/california-adds-second-law-in-one-week-targeting-healthcare-investmentsSidley UpdatesCalifornia Adds Second Law in One Week Targeting Healthcare InvestmentsTue, 14 Oct 2025 05:00:00 Z{B388160D-BB8A-4DE5-8EC9-D5A749A68BBC}https://www.sidley.com/ja/insights/newsupdates/2025/10/inflation-reduction-act-cms-publishes-final-guidance-for-initial-price-applicability-year-2028Sidley UpdatesInflation Reduction Act: CMS Publishes Final Guidance for Initial Price Applicability Year 2028Thu, 09 Oct 2025 05:00:00 Z{88576A72-1092-4C80-A0CC-37B58E53CBF6}https://www.sidley.com/ja/insights/newsupdates/2025/10/newly-enacted-california-law-formalizes-corporate-practice-restrictionsSidley UpdatesNewly Enacted California Law Formalizes Corporate Practice RestrictionsWed, 08 Oct 2025 05:00:00 Z{1964174B-39C5-4B1A-93CC-7012B1EAAEF1}https://www.sidley.com/ja/insights/newsupdates/2025/10/adapting-to-change-key-compliance-risks-under-the-revised-eu-pharmacovigilance-rulesSidley UpdatesAdapting to Change Key Compliance Risks Under the Revised EU Pharmacovigilance RulesWed, 08 Oct 2025 05:00:00 Z{AF380A21-D395-4F81-BEAE-911D8DB3FC91}https://www.sidley.com/ja/insights/newsupdates/2025/09/paths-forward-in-the-wake-of-fdas-crackdown-on-prescription-drug-adsSidley UpdatesPaths Forward in the Wake of FDA’s “Crackdown” on Prescription Drug AdsFri, 26 Sep 2025 05:00:00 Z{6A6D70B5-5491-48D8-B056-C8BF0A3E3771}https://www.sidley.com/ja/insights/newsupdates/2025/09/fdas-alternative-tools-guidance-promises-a-flexible-approach-for-manufacturing-facility-assessmentsSidley UpdatesFDA’s Alternative Tools Guidance Promises a Flexible Approach for Manufacturing Facility AssessmentsThu, 18 Sep 2025 05:00:00 Z{BF0282C1-A3F0-44DF-8C88-39CF1DD3B08C}https://www.sidley.com/ja/insights/newsupdates/2025/09/rare-disease-and-specialty-product-manufacturers-distribution-model-considerationsSidley UpdatesRare Disease and Specialty Product Manufacturers: Distribution Model ConsiderationsTue, 16 Sep 2025 05:00:00 Z{49A07424-2E82-4BAD-83A4-460050DA52A8}https://www.sidley.com/ja/insights/newsupdates/2025/09/evolving-veterinary-pharmacovigilance-frameworks-in-europeSidley UpdatesEvolving Veterinary Pharmacovigilance Frameworks in Europe: What Manufacturers Need to KnowMon, 15 Sep 2025 05:00:00 Z{DF68F06A-2D8F-4A9C-B350-D14FCF017593}https://www.sidley.com/ja/insights/newsupdates/2025/08/new-digital-health-ecosystem-and-hipaa-flexibilities-facilitate-sharing-of-patientSidley UpdatesNew Digital Health Ecosystem and HIPAA Flexibilities Facilitate Sharing of Patient Health InformationFri, 29 Aug 2025 05:00:00 Z{D38838EF-BA7C-4331-860B-F3BE13CEC17A}https://www.sidley.com/ja/insights/newsupdates/2025/07/lab-compliance-companion-diagnostic-testing-arrangement-approved-by-hhsSidley UpdatesLab Compliance: Companion Diagnostic Testing Arrangement Approved by HHS Office of Inspector GeneralThu, 24 Jul 2025 05:00:00 Z{6D41037F-641F-4DC2-A995-0E34D1E7180D}https://www.sidley.com/ja/insights/newsupdates/2025/07/key-medicare-reimbursement-policies-under-the-microscope-in-proposed-ruleSidley UpdatesKey Medicare Reimbursement Policies Under the Microscope in Proposed RuleThu, 24 Jul 2025 05:00:00 Z{D691DE81-A1E2-4913-ABD3-2AE86BBD9BF3}https://www.sidley.com/ja/insights/newsupdates/2025/07/early-stage-life-sciences-partnerships-raise-later-stage-considerationsSidley UpdatesEarly-Stage Life Sciences Partnerships Raise Later-Stage ConsiderationsMon, 21 Jul 2025 05:00:00 Z{47167045-1268-4DB1-8F1E-A944DE3A6FCE}https://www.sidley.com/ja/insights/newsupdates/2025/07/major-us-government-price-reporting-proposals-warrant-industry-commentSidley UpdatesMajor U.S. Government Price Reporting Proposals Warrant Industry CommentFri, 18 Jul 2025 05:00:00 Z{3A941B0D-581A-443F-9F7A-255DD9C318C6}https://www.sidley.com/ja/insights/newsupdates/2025/07/key-inflation-reduction-act-amendment-broadens-us-protection-for-orphan-drugsSidley UpdatesKey Inflation Reduction Act Amendment Broadens U.S. Protection for Orphan DrugsTue, 15 Jul 2025 05:00:00 Z{2698812C-71F6-4D9A-90B5-A27A7426A3F7}https://www.sidley.com/ja/insights/newsupdates/2025/07/fda-release-of-complete-response-letters-raises-confidentiality-and-disclosure-questionsSidley UpdatesFDA Release of Complete Response Letters Raises Confidentiality, Disclosure Questions But Offers Insights for DevelopmentFri, 11 Jul 2025 05:00:00 Z{28FABD1C-59B8-4743-8000-AF407F07050F}https://www.sidley.com/ja/insights/newsupdates/2025/07/us-fda-publishes-final-guidance-for-remote-regulatory-assessmentsSidley UpdatesU.S. FDA Publishes Final Guidance for Remote Regulatory AssessmentsMon, 07 Jul 2025 05:00:00 Z{B74B9AC0-0EE8-4535-BA68-D56B80F05B2B}https://www.sidley.com/ja/insights/newsupdates/2025/06/eu-limits-chinese-participation-in-medical-devices-procurementSidley UpdatesEU Limits Chinese Participation in Medical Devices ProcurementMon, 30 Jun 2025 05:00:00 Z{E828ED31-5CEF-43A4-9D38-AD21FBB33AC0}https://www.sidley.com/ja/insights/newsupdates/2025/06/us-fda-revises-deadline-for-submitting-changes-to-mitigate-nitrosamine-impurities-in-drugsSidley UpdatesU.S. FDA Revises Deadline for Submitting Changes to Mitigate Nitrosamine Impurities in Drugs (June 2025)Wed, 25 Jun 2025 05:00:00 Z{1AA46C29-13F0-4C2D-B2EC-BB6EABFE0D91}https://www.sidley.com/ja/insights/newsupdates/2025/06/fda-finalizes-guidance-for-generic-drug-manufacturers-seeking-post-warning-letter-meetingsSidley UpdatesFDA Finalizes Guidance for Generic Drug Manufacturers Seeking Post-Warning Letter MeetingsTue, 24 Jun 2025 05:00:00 Z{63F34AF7-75A9-47CA-A65A-0E60CDF2179C}https://www.sidley.com/ja/insights/newsupdates/2025/06/us-doj-civil-division-to-investigate-possible-violations-of-the-fdca-by-pharmaceutical-companiesSidley UpdatesU.S. DOJ Civil Division to Investigate Possible Violations of the Food, Drug, and Cosmetic Act by Pharmaceutical Firms Manufacturing Drugs Used in Gender Transition CareMon, 23 Jun 2025 05:00:00 Z{C9D19280-CAFF-4912-A6C8-38ADE25CAE62}https://www.sidley.com/ja/insights/newsupdates/2025/06/oregon-revises-corporate-practice-of-medicine-lawSidley UpdatesOregon Revises Corporate Practice of Medicine Law: Implementing More Restrictions on Corporate Involvement in Medical PracticesThu, 12 Jun 2025 05:00:00 Z{967F4A66-66EB-4B97-B7FF-18BA6D3CDAA5}https://www.sidley.com/ja/insights/newsupdates/2025/05/us-cms-sets-stage-for-2028-medicare-drug-price-negotiationsSidley UpdatesCMS Sets Stage for 2028 Medicare Drug Price Negotiations — First Look at Negotiations for Part BWed, 21 May 2025 05:00:00 Z{9156F783-236E-4EE7-A4DB-AC1D3DCA0390}https://www.sidley.com/ja/insights/newsupdates/2025/05/most-favored-nation-drug-pricing-executive-order-signals-potential-us-major-policy-shiftSidley UpdatesMost-Favored-Nation Drug Pricing: Executive Order Sets Forth Potential U.S. Major Policy ShiftThu, 15 May 2025 05:00:00 Z{074DB137-0752-4964-B534-3CD8ACD17443}https://www.sidley.com/ja/insights/newsupdates/2025/05/strict-liability-in-the-crosshairs-executive-order-reshapes-criminal-enforcement-of-the-fdcaSidley UpdatesStrict Liability in the Crosshairs: Executive Order Reshapes Criminal Enforcement of the U.S. Federal Food, Drug, and Cosmetic ActWed, 14 May 2025 05:00:00 Z{E15D1216-BEB2-4DCD-ABDE-C6D92A5573BB}https://www.sidley.com/ja/insights/newsupdates/2025/05/medicare-reimbursement-pathway-for-ai-enabled-medical-devices-consideredSidley UpdatesMedicare Reimbursement Pathway for AI-Enabled Medical Devices Considered in Senate’s Health Tech Investment ActTue, 13 May 2025 05:00:00 Z{04C0D967-F7F5-4948-8937-4B1F9554D00F}https://www.sidley.com/ja/insights/newsupdates/2025/05/us-fda-plans-to-increase-the-number-of-surprise-foreign-inspectionsSidley UpdatesU.S. FDA Plans to Increase the Number of Surprise Foreign InspectionsWed, 07 May 2025 05:00:00 Z{2AE68683-F756-4F18-BF85-C38B7724D7C7}https://www.sidley.com/ja/insights/newsupdates/2025/05/federal-court-clarifies-medicaid-rebate-reporting-requirements-for-new-strengthsSidley UpdatesFederal Court Clarifies Medicaid Rebate Reporting Requirements for New StrengthsWed, 07 May 2025 05:00:00 Z