Food, Drug, and Medical Device Compliance and Enforcement Sidley Updateshttps://www.sidley.com/ja/rss/fdmd-compliance-and-enforcement-sidley-updatesja60{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{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{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{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{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{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{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{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{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{8D80D31F-A141-4B90-BD75-9220EF5C1C43}https://www.sidley.com/ja/insights/newsupdates/2025/08/physician-owned-medical-device-arrangement-approved-by-hhs-oigSidley UpdatesPhysician-Owned Medical Device Arrangement Approved by HHS-OIGWed, 20 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{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{42014500-010E-4F5F-9B1E-E831C49B3770}https://www.sidley.com/ja/insights/newsupdates/2025/07/us-doj-announces-renewal-of-fca-working-groupSidley UpdatesU.S. DOJ Announces Renewal of FCA Working GroupMon, 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{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{0485151A-3A79-45FD-8E5E-643B496741F2}https://www.sidley.com/ja/insights/newsupdates/2025/05/maha-commission-reportSidley UpdatesMAHA Commission Report: Broad Review of Food, Agriculture, and Pharmaceutical Drivers of Human Disease with a Self-Described Call to ActionWed, 28 May 2025 05:00:00 Z{3FEEA4CD-EF92-42DA-ABBD-2DE5C2B17824}https://www.sidley.com/ja/insights/newsupdates/2025/05/regulatory-rollback-and-rebrand-of-fdas-human-foods-programSidley UpdatesRegulatory Rollback and Rebrand of FDA's Human Foods ProgramThu, 22 May 2025 05:00:00 Z{53955805-7EAE-444F-B7FD-ED5FFC5232C9}https://www.sidley.com/ja/insights/newsupdates/2025/05/arkansas-passes-legislation-that-restricts-drug-manufacturers-limited-distribution-networksSidley UpdatesArkansas Passes Legislation Restricting Drug Manufacturers' Limited Distribution NetworksWed, 14 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