<rss xmlns:a10="http://www.w3.org/2005/Atom" version="2.0"><channel><title>Food, Drug, and Medical Device Regulatory Sidley Updates</title><link>https://www.sidley.com/zh-hans/rss/fdmd-regulatory-sidley-updates</link><description /><language>zh-Hans</language><ttl>60</ttl><item><guid isPermaLink="false">{BB6EFD8B-217C-4D35-BC47-69283CB855BB}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2026/04/us-fda-issues-first-drug-supply-chain-security-act-warning-letter-targeting-a-dispenser</link><category>盛德动态</category><title>U.S. FDA Issues First Drug Supply Chain Security Act Warning Letter Targeting a Dispenser, Signaling Expanded Enforcement Focus</title><description /><pubDate>Wed, 15 Apr 2026 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{41D430B5-2A58-4250-B4B1-E7D35D2F624A}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2026/02/veterinary-biologics-and-biosimilars-routes-to-approval-and-commercialization-in-the-us-eu-and-uk</link><category>盛德动态</category><title>Veterinary Biologics and Biosimilars: Routes to Approval and Commercialization in the U.S., EU, and UK</title><description /><pubDate>Fri, 20 Feb 2026 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{4FD37680-D6A6-4C4E-87FB-0EB723B27090}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2026/01/medical-products-market-access-favorable-advisory-opinion-reaffirms-discounting-flexibilities</link><category>盛德动态</category><title>Medical Products Market Access: Favorable Advisory Opinion Reaffirms Discounting Flexibilities</title><description /><pubDate>Wed, 21 Jan 2026 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{93EB3131-3AC6-4649-925E-BCD084C1C126}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2026/01/impact-of-fda-warning-letters-in-europe-practical-considerations-for-industry</link><category>盛德动态</category><title>Impact of U.S. FDA Warning Letters in Europe: Practical Considerations for Industry</title><description /><pubDate>Mon, 12 Jan 2026 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{98235C28-1F65-4421-A2DB-3CB95D7832A0}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2026/01/top-10-areas-we-watching-for-2026</link><category>盛德动态</category><title>Top 10 FDA Areas We Are Watching For 2026</title><description>As 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.</description><pubDate>Mon, 12 Jan 2026 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{B7654E8E-8185-416F-86FD-76BFE038E8E4}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/12/biosecure-act-included-in-the-fy2026-national-defense-authorization-act</link><category>盛德动态</category><title>BIOSECURE Act Included in the FY2026 National Defense Authorization Act</title><description /><pubDate>Fri, 12 Dec 2025 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{80BB087E-FE40-4CAB-969D-7F1F33BA4490}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/12/what-the-us-uk-drug-pricing-agreement-reveals-about-how-mfn-drug-policy-could-impact-the-uk-and-eu</link><category>盛德动态</category><title>What the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EU</title><description /><pubDate>Wed, 10 Dec 2025 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{95E5F542-933E-4EC4-BFF5-0B1DDD6B50C5}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/12/us-fdas-adoption-of-ich-e6r3-good-clinical-practice-key-takeaways-for-sponsors-and-investigators</link><category>盛德动态</category><title>U.S. FDA's Adoption of ICH E6(R3) Good Clinical Practice: Key Takeaways for Sponsors and Investigators</title><description /><pubDate>Thu, 04 Dec 2025 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{475B293B-BC7A-4153-B69C-75EB1917ABED}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/11/us-fda-and-cms-actions-on-generative-ai-enabled-mental-health-devices-yield-insights-across-ai</link><category>盛德动态</category><title>U.S. FDA and CMS Actions on Generative AI-Enabled Mental Health Devices Yield Insights Across AI Product Development</title><description /><pubDate>Wed, 12 Nov 2025 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{8A344660-AAA7-495D-9E49-06F7060CE33D}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/11/cms-announces-voluntary-most-favored-nation-pricing-in-medicaid-through-the-generous-model</link><category>盛德动态</category><title>CMS Announces Voluntary Most-Favored-Nation Pricing in Medicaid Through the GENEROUS Model</title><description /><pubDate>Tue, 11 Nov 2025 06:00:00 Z</pubDate></item><item><guid isPermaLink="false">{AF380A21-D395-4F81-BEAE-911D8DB3FC91}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/09/paths-forward-in-the-wake-of-fdas-crackdown-on-prescription-drug-ads</link><category>盛德动态</category><title>Paths Forward in the Wake of FDA’s “Crackdown” on Prescription Drug Ads</title><description /><pubDate>Fri, 26 Sep 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{BF0282C1-A3F0-44DF-8C88-39CF1DD3B08C}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/09/rare-disease-and-specialty-product-manufacturers-distribution-model-considerations</link><category>盛德动态</category><title>Rare Disease and Specialty Product Manufacturers: Distribution Model Considerations</title><description /><pubDate>Tue, 16 Sep 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{49A07424-2E82-4BAD-83A4-460050DA52A8}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/09/evolving-veterinary-pharmacovigilance-frameworks-in-europe</link><category>盛德动态</category><title>Evolving Veterinary Pharmacovigilance Frameworks in Europe: What Manufacturers Need to Know</title><description /><pubDate>Mon, 15 Sep 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{797B1814-BB2C-46CA-A3B2-1BDE3BEC9A43}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/07/whats-in-fdas-fy-2026-legislative-request-key-proposals-to-watch</link><category>盛德动态</category><title>What’s in U.S. FDA’s Fiscal 2026 Legislative Request? Key Proposals to Watch</title><description /><pubDate>Wed, 23 Jul 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{42014500-010E-4F5F-9B1E-E831C49B3770}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/07/us-doj-announces-renewal-of-fca-working-group</link><category>盛德动态</category><title>U.S. DOJ Announces Renewal of FCA Working Group</title><description /><pubDate>Mon, 07 Jul 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{28FABD1C-59B8-4743-8000-AF407F07050F}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/07/us-fda-publishes-final-guidance-for-remote-regulatory-assessments</link><category>盛德动态</category><title>U.S. FDA Publishes Final Guidance for Remote Regulatory Assessments</title><description /><pubDate>Mon, 07 Jul 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{1AA46C29-13F0-4C2D-B2EC-BB6EABFE0D91}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/06/fda-finalizes-guidance-for-generic-drug-manufacturers-seeking-post-warning-letter-meetings</link><category>盛德动态</category><title>FDA Finalizes Guidance for Generic Drug Manufacturers Seeking Post-Warning Letter Meetings</title><description /><pubDate>Tue, 24 Jun 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{63F34AF7-75A9-47CA-A65A-0E60CDF2179C}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/06/us-doj-civil-division-to-investigate-possible-violations-of-the-fdca-by-pharmaceutical-companies</link><category>盛德动态</category><title>U.S. DOJ Civil Division to Investigate Possible Violations of the Food, Drug, and Cosmetic Act by Pharmaceutical Firms Manufacturing Drugs Used in Gender Transition Care</title><description /><pubDate>Mon, 23 Jun 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{0485151A-3A79-45FD-8E5E-643B496741F2}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/05/maha-commission-report</link><category>盛德动态</category><title>MAHA Commission Report: Broad Review of Food, Agriculture, and Pharmaceutical Drivers of Human Disease with a Self-Described Call to Action</title><description /><pubDate>Wed, 28 May 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{3FEEA4CD-EF92-42DA-ABBD-2DE5C2B17824}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/05/regulatory-rollback-and-rebrand-of-fdas-human-foods-program</link><category>盛德动态</category><title>Regulatory Rollback and Rebrand of FDA's Human Foods Program</title><description /><pubDate>Thu, 22 May 2025 05:00:00 Z</pubDate></item><item><guid isPermaLink="false">{967F4A66-66EB-4B97-B7FF-18BA6D3CDAA5}</guid><link>https://www.sidley.com/zh-hans/insights/newsupdates/2025/05/us-cms-sets-stage-for-2028-medicare-drug-price-negotiations</link><category>盛德动态</category><title>CMS Sets Stage for 2028 Medicare Drug Price Negotiations — First Look at Negotiations for Part B</title><description /><pubDate>Wed, 21 May 2025 05:00:00 Z</pubDate></item></channel></rss>