https://www.morganlewis.com/rss/blogsBlogs RSS Feed25https://www.morganlewis.com/blogs/asprescribed/2026/04/fdas-warning-letter-suggests-growing-scrutiny-of-ai-overrelianceA recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not the first FDA Warning Letter related to AI, prior Warning Letters focused on issues surrounding the regulatory status of the AI systems themselves, namely whether a given AI system was a medical device subject to FDA oversight.Fri, 24 Apr 2026 00:00:00 -05001ccb5e31-3e56-452e-a316-90073c52481cLitigation, Regulation & InvestigationsFDA & HealthcareUnited StatesLife SciencesMedical DevicesTechnologyArtificial IntelligenceLITFDAMichele L. BuenafeAriel Z. Seeleyhttps://www.morganlewis.com/blogs/asprescribed/2026/03/fda-grants-first-voucher-under-restored-pediatric-disease-programFDA recently announced the issuance of the first voucher awarded under its restored Rare Pediatric Disease (RPD) Priority Review Voucher Program for a drug that was approved after the program’s previous sunset. The Consolidated Appropriations Act, signed into law on February 3, 2026, reintroduced voucher availability for RPD-designated drugs and created a safety net for designations made when vouchers were not immediately available.Thu, 19 Mar 2026 00:00:00 -050079b36a2b-1f8b-434e-9519-d9c45df97f6dFDA & HealthcareLitigation, Regulation & InvestigationsUnited StatesLife SciencesFDALITMaarika L. KimbrellOwen G. Hosseinzadehhttps://www.morganlewis.com/blogs/asprescribed/2026/03/the-impact-of-the-eu-pharma-package-on-the-ukAs readers will be aware, at the end of 2025, the EU institutions agreed the text of the EU Pharma Package: the wholesale change to the pharmaceutical regime in the EU that has been debated for many years. The changes introduce wide ranging amendments that impact rewards and exclusivities, supply chain set up, and procedures for generics and biosimilars.Fri, 06 Mar 2026 00:00:00 -0600c36f56f3-ccb5-4e79-a25d-d433dd9f8e17Intellectual PropertyEuropeUnited KingdomHealthcarePharmaceuticals & BiotechnologyLife SciencesIPJackie Mulrynehttps://www.morganlewis.com/blogs/asprescribed/2026/02/uk-pmcpa-refreshes-social-media-guidance-what-in-house-teams-should-knowThe UK Prescription Medicines Code of Practice Authority (PMCPA) has published revised social media guidance in a new dedicated section of its website , reflecting recent case precedent and the realities of an evolving digital landscape.Thu, 19 Feb 2026 00:00:00 -06004de7d8b0-978b-4454-8a99-b786a992727aFDA & HealthcareEuropeUnited StatesLife SciencesFDAJackie MulryneJasmeen Bahoushttps://www.morganlewis.com/blogs/asprescribed/2026/02/new-year-new-guidance-fda-revisits-wellness-and-cds-boundariesThe FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release; instead, FDA Commissioner Makary took to social media to announce the updates in a video, in which he touted them as “promot[ing] more innovation with AI and medical devices” and that FDA has “a clear lane for medical grade products,” but needs “to adapt with the times and be proactive with guidance.” Consistent with the Commissioner’s messaging, the updates to the General Wellness guidance expand the types of products that qualify for enforcement discretion (i.e., do not need to comply with FDA’s device requirements). The updates to the CDS guidance, however, do not appear to significantly modify FDA’s interpretation of the CDS exemption. Nonetheless, these updated guidance documents signal FDA leadership’s willingness to ease regulatory burdens for digital health and wearables.Fri, 06 Feb 2026 00:00:00 -06006ff0f45e-e54d-48f1-beff-2faf8131a0ceFDA & HealthcareWhite Collar Litigation & Government InvestigationsLife SciencesFDALITMichele L. BuenafeAriel Z. SeeleySydney Menackhttps://www.morganlewis.com/blogs/asprescribed/2026/01/key-takeaways-from-the-2026-jp-morgan-healthcare-conferenceThe Morgan Lewis cross-functional and cross-jurisdiction life sciences and healthcare teams were represented in San Francisco for the 44th Annual J.P. Morgan Healthcare Conference from January 12–15, 2026. The conference reinforced a familiar but evolving message for the life sciences and healthcare industries: capital remains constrained, exits are uncertain, and success increasingly depends on scale, optionality, strategic, and regulatory clarity. While the outlook for a potential reopening of public markets remains positive, structural shifts in funding, dealmaking, and investor behavior appear more enduring. This blog post discusses the principal themes that emerged from panels and private discussions throughout the week in the areas of life sciences dealmaking and the evolving regulatory landscape for medical products.Mon, 26 Jan 2026 00:00:00 -0600b6b0fbed-653c-4fc8-8136-44d2f0ee497fFDA & HealthcareLife Sciences TransactionsUnited StatesEuropeAsiaLife SciencesHealthcareArtificial IntelligenceFDALSLuciana GriebelJeanna Palmer GunvilleMaarika L. KimbrellJackie MulryneAlia M. Orbin, Ph.D.Benjamin H. PensakBen (Byunghwi) Rhohttps://www.morganlewis.com/blogs/asprescribed/2026/01/awash-in-data-fda-removes-a-barrier-in-real-world-evidence-generationOn December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device regulatory submissions. Namely, for certain types of medical device submissions, sponsors may not need to provide individually identifiable source data when using RWE. FDA also indicated that it intends to consider making a similar change for drugs and biologics signaling that there could be a broader shift in FDA policy coming, meaning that medical product developers of all types should be paying attention to FDA developments in this area.Tue, 20 Jan 2026 00:00:00 -0600d7ff4f56-e9c9-4b69-a541-73b977378d95FDA & HealthcareUnited StatesLife SciencesFDAAriel Z. SeeleyMaarika L. Kimbrellhttps://www.morganlewis.com/blogs/asprescribed/2026/01/breakthrough-devices-around-the-world-opportunities-and-challenges-in-the-us-and-euThe US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and enhanced communication with regulators. Despite its promise, only a small percentage of devices granted Breakthrough designation have achieved marketing authorization, reflecting persistent regulatory and evidentiary hurdles.Thu, 08 Jan 2026 00:00:00 -0600855da7d5-129b-4aac-996d-a0cd4d2c2c2dFDA & HealthcareIntellectual PropertyEuropeUnited StatesLife SciencesFDAIPJackie MulryneAriel Z. Seeleyhttps://www.morganlewis.com/blogs/asprescribed/2026/01/the-european-commission-proposes-biotech-act-to-support-development-of-biotech-productsAt the end of 2025, as part of a bundle of measures to make the EU health sector more innovative, competitive and resilient, the European Commission proposed the EU Biotech Act (the Act) aimed at repositioning the EU as a global biotechnology hub. It includes a wide range of proposals, such as access to funding, streamlined regulatory processes, and increased incentives for innovative products. The proposal signals that the EU institutions are attempting to make the EU a more pro-innovation environment, and many of the proposals will likely be welcomed by industry.Mon, 05 Jan 2026 00:00:00 -060002b635e0-52aa-4bf5-ad63-e804d431d585FDA & HealthcareIntellectual PropertyEuropeLife SciencesFDAIPJackie MulryneKulraj Singh Bhangra, Ph.D.https://www.morganlewis.com/blogs/asprescribed/2025/12/european-commission-issues-proposal-to-simplify-medical-devices-regulationsIn a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices . The key elements of the revisions are summarized in a factsheet and in a questions and answers document .Wed, 17 Dec 2025 00:00:00 -060000210db3-c22e-4c47-bf01-dd04a8a8e125FDA & HealthcareEuropeLife SciencesMedical DevicesFDAJackie Mulrynehttps://www.morganlewis.com/blogs/asprescribed/2025/12/agreement-reached-on-eu-pharma-package-but-questions-remainTwo and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical framework for medicinal products, which is currently based on legislation dating back to 2001.Fri, 12 Dec 2025 00:00:00 -0600f00dae80-e756-4cb2-bf0a-99ad667e4696FDA & HealthcareEuropeLife SciencesFDAJackie Mulrynehttps://www.morganlewis.com/blogs/asprescribed/2025/12/new-fda-digital-health-pilot-same-fda-enforcement-discretionOn December 8, 2025, FDA announced a pilot for certain digital health devices in connection with the Center for Medicare and Medical Innovation’s (CMMI’s) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) payment model.Thu, 11 Dec 2025 00:00:00 -0600afc531f6-0e68-4fd4-bcab-934ed008243eFDA & HealthcareUnited StatesLife SciencesFDAAriel Z. Seeleyhttps://www.morganlewis.com/blogs/asprescribed/2025/12/impacts-of-fdas-slimming-of-biosimilar-requirementsFDA recently issued a new draft guidance titled Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies, which proposes omitting comparative efficacy studies (CES) where appropriate “based on the totality of the evidence” to instead rely only on analytical, PK/PD, and immunogenicity data to inform biosimilarity determinations. As the agency explains, it has gained substantial experience with comparative analytical assessments (CAA) and now wants to update its framework for determining when a CES may not be necessary to support biosimilarity.Thu, 04 Dec 2025 00:00:00 -0600a4bb4b95-4293-4abe-9384-5b31e9f93ddbFDA & HealthcareUnited StatesLife SciencesFDAMaarika L. KimbrellChristina A. MacDougall, Ph.D.Owen G. Hosseinzadehhttps://www.morganlewis.com/blogs/asprescribed/2025/12/date-set-for-mandatory-application-of-european-database-on-medical-devicesThe European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the European database on medical devices (EUDAMED).Tue, 02 Dec 2025 00:00:00 -06006aab75eb-75c4-470e-b955-b9e96b5cccd1FDA & HealthcareUnited StatesEuropeLife SciencesFDAJackie Mulrynehttps://www.morganlewis.com/blogs/asprescribed/2025/11/major-overhaul-of-uk-rare-disease-regulation-mhra-proposes-enhanced-frameworkThe UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to introduce sweeping reforms for accelerating rare disease therapy development and approval, with the aim to position the UK as a global leader in the field. The new framework will put in place flexible licensing for rare disease therapies with adaptive trial design and a new “investigational marketing authorization.” It will also ensure a patient-centered approach with an emphasis on transparency, flexible benefit-risk thresholds, and use of real-world evidence.Wed, 12 Nov 2025 00:00:00 -06007dd32848-28c5-4f82-8aa1-b444a4fea85dFDA & HealthcareUnited StatesEuropeLife SciencesPharmaceuticals & BiotechnologyFDAJackie MulryneMaarika L. KimbrellLuciana Griebelhttps://www.morganlewis.com/blogs/asprescribed/2025/11/from-vulnerability-to-violation-fda-cybersecurity-requirements-for-medical-devices-and-fca-enforcementIn June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 Cybersecurity Guidance). This guidance updates the 2023 guidance of the same title with the agency’s interpretation of and compliance recommendations for new requirements for “cyber devices” under Section 524B of the Federal Food, Drug, and Cosmetic Act (FFDCA). These new statutory cybersecurity requirements, enacted in December 2022 as part of the Food and Drug Omnibus Reform Act (FDORA), are starting to take centerstage as the medical device sector begins to address new enforcement risks for cybersecurity deficiencies under more traditional fraud and abuse laws, such as the False Claims Act (FCA).Wed, 05 Nov 2025 00:00:00 -0600d49f65d3-a358-4b0b-ae7c-e28e4a893250FDA & HealthcareCybersecurity, Incident Response & PrivacyFalse Claims Act & Qui Tam LitigationUnited StatesLife SciencesFDAACCPLITAriel Z. SeeleyJonathan P. YorkHeather EganHannah Levinhttps://www.morganlewis.com/blogs/asprescribed/2025/10/fdas-evolving-complete-response-letter-disclosure-practices-impacts-and-considerationsWith the recent publication of numerous, previously unpublished complete response letters, coupled with its plans to increase these disclosures going forward, FDA has taken a significant step forward in its previously stated commitments to transparency. FDA has framed this initiative as a way to assist drug developers in learning from prior deficiencies, to ensure that the public has accurate information regarding FDA’s assessment of applications and to strengthen public trust in FDA’s decision-making. However, applicants should be aware of these changing practices, FDA’s obligations in regard to them, and proactively consider and potentially adjust current practices in reaction to this changing landscape.Wed, 08 Oct 2025 00:00:00 -05005b5f6010-fa00-4728-928a-67df81cd1043FDA & HealthcareLife SciencesFDAMaarika L. KimbrellAmanda S. WilliamsonAriel Z. Seeleyhttps://www.morganlewis.com/blogs/asprescribed/2025/10/marketing-medical-devices-navigating-increased-fda-scrutinyWith the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC) prescription drug advertising, and the subsequent issuance of more than 100 “cease and desist” letters, the agency has demonstrated it believes that DTC marketing of prescription drugs may have gone too far and that it is committed to bringing the industry back into regulatory compliance.Fri, 03 Oct 2025 00:00:00 -050021c2fe6d-1431-4449-a1aa-cefcccf4d7a8FDA & HealthcareAdvertising & MarketingLife SciencesMedical DevicesFDALITAriel Z. Seeleyhttps://www.morganlewis.com/blogs/asprescribed/2025/09/fda-announces-crackdown-on-dtc-advertising-what-it-means-for-pharma-and-what-comes-nextThe White House issued a memorandum on September 9, 2025 directing the secretary of the US Department of Health and Human Services (HHS) and the commissioner of the US Food and Drug Administration (FDA) to significantly increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA) and its rules governing direct-to-consumer (DTC) prescription drug advertising. In response, FDA issued an announcement regarding planned rulemaking and more immediate enforcement actions and strategies.Mon, 15 Sep 2025 00:00:00 -0500394302d3-b3e9-44f8-8630-a3eabd15e71fFDA & HealthcareLife SciencesFDAMaarika L. KimbrellJacqueline R. BermanMichele L. BuenafeScott A. MemmottAriel Z. SeeleySydney Menackhttps://www.morganlewis.com/blogs/asprescribed/2025/09/vaccine-suspension-fda-leans-into-its-withdrawal-toolbox-but-will-it-invite-challengesOn August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental biologics license application for the vaccine product, due in part to subsequent VAERS reports of “chikungunya-like illness” in relatively healthy individuals under the age of 65.Thu, 04 Sep 2025 00:00:00 -050017e7dd41-e962-4144-b3d9-4850646ab68eFDA & HealthcareLife SciencesFDAMaarika L. KimbrellOwen G. Hosseinzadehhttps://www.morganlewis.com/blogs/asprescribed/2025/08/a-clearer-path-from-fda-for-minor-changes-to-solid-oral-dosage-forms-for-otc-monograph-drugsRecent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured, incremental approach to innovation. The FDA docket is open until October 3 for comments.Fri, 15 Aug 2025 00:00:00 -0500567e36d4-581d-4e77-b5a7-1eb5f82960ffFDA & HealthcareLife SciencesFDASydney Menackhttps://www.morganlewis.com/blogs/asprescribed/2025/08/doj-announces-first-fca-settlement-with-medical-device-company-for-cybersecurity-violationsThe US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The cybersecurity framework, typically seen in other industries such as defense contracting, serves as a warning to companies in the life sciences, medtech, and digital health space that DOJ and the whistleblower bar are expanding the scope of this flavor of FCA enforcement and should prepare accordingly.Tue, 12 Aug 2025 00:00:00 -0500573f2655-0ba7-4f95-94aa-ff3caa653f86FDA & HealthcareLife SciencesFDAJonathan P. YorkMichele L. BuenafeB. Scott McBrideScott A. Memmotthttps://www.morganlewis.com/blogs/asprescribed/2025/08/fdas-new-priority-voucher-program-for-drug-developers-ties-incentives-to-defined-national-interestsThe US Food and Drug Administration recently announced the launch of a regulatory incentive pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors that align their development activities with specific US national interests.Mon, 11 Aug 2025 00:00:00 -0500adc23417-cb41-46ac-b723-5ca7e215808eFDA & HealthcareLife SciencesFDAMaarika L. Kimbrellhttps://www.morganlewis.com/blogs/asprescribed/2025/07/orphan-drugs-big-breaks-the-quiet-carve-out-in-the-one-big-beautiful-bill-actThe One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be insulated from consideration in Medicare drug price negotiations. By redefining the qualifications for negotiation eligibility, the bill hopes to create opportunity for renewed innovation for orphan drug products.Wed, 30 Jul 2025 00:00:00 -05009e7ff9e2-4d5f-4d39-938e-b51741cd4659FDA & HealthcareLife SciencesFDAKathleen M. SanzoRachel L. Lamparellihttps://www.morganlewis.com/blogs/asprescribed/2025/07/fdas-shifting-stance-on-public-disclosure-of-nda-and-bla-complete-response-letters-how-far-will-it-goThe US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025 FDA compiled and released more than 200 CRLs issued between 2020 and 2024 for approved new drug application (NDA) and biologics license application (BLA) products. Improving on past agency practice, these CRLs are now located within a single database, providing the public with easy access to a trove of information regarding FDA’s thinking when making approval decisions.Tue, 15 Jul 2025 00:00:00 -0500a95a347a-38bf-4a7a-83bd-943259e8c187FDA & HealthcareLife Sciences TransactionsHealthcareLife SciencesFDALSMaarika L. KimbrellJacqueline R. BermanFrederick L. BlockDavid G. GlazerCarolyn M. Welshhans