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Articles by Daniel Kracov
FDA Releases Proposed PDUFA VIII Commitment Letter
Eva Temkin’s articles from Arnold & Porter are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) with readers working within the Business & Consumer Services, Healthcare and Media & Information industries Arnold & Porter are most popular: within Strategy and International Law topic(s) On August 14, 2026, the U.S. Food and Drug Administration (FDA) published a notice seeking public input on the proposed eighth commitment letter for the Prescription Drug User Fee Act...
FDA Releases Proposed PDUFA VIII Commitment Letter
On August 14, 2026, the U.S. Food and Drug Administration (FDA) published a notice seeking public input on the proposed eighth commitment letter for the Prescription Drug User Fee Act (PDUFA VIII), which would cover fiscal years (FY) 2028 through 2032 (proposed Commitment Letter).1 The current PDUFA VII authorization expires in September 2027, and new legislation will be required for FDA to continue collecting prescription drug user fees after that date.
FDA Issues Revised Draft Guidance On Demonstrating Substantial Evidence Of Effectiveness For Human Drugs And Biological Products
AP Arnold & Porter More Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
FDA Proposes Expedited Investigational New Drug Pilot Program To Drive Early Phase Clinical Research In The United States
Arnold & Porter are most popular: within Cannabis & Hemp, Media, Telecoms, IT, Entertainment and Strategy topic(s) On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States.1 As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical...
FDA Issues Revised Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products
On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States.1 As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development, including: proposing a pilot program intended to reduce the start-up time for first-in-human (FIH)...
FDA Proposes Expedited Investigational New Drug Pilot Program to Drive Early Phase Clinical Research in the United States
On June 22, 2026, the U.S. Department of Health and Human Services (HHS) unveiled Operation TrialBlazer, a department-wide effort to accelerate clinical research and development centered in the United States.1 As part of that initiative, the U.S. Food and Drug Administration (FDA or the Agency) is taking multi-pronged actions to help facilitate early- and late-stage clinical development, including: proposing a pilot program intended to reduce the start-up time for first-in-human (FIH)...
National Security Controls And The Life Sciences Sector: BIOSECURE Act, Section 1260H, And COINS Act Developments
Arnold & Porter are most popular: within Cannabis & Hemp, Media, Telecoms, IT and Entertainment topic(s) The life sciences sector continues to be a growing area of interest for national security controls, as U.S. pharmaceutical companies have increasingly partnered with Chinese firms for development, manufacturing, and licensing arrangements.
National Security Controls and the Life Sciences Sector: BIOSECURE Act, Section 1260H, and COINS Act Developments
Executive Summary The life sciences sector continues to be a growing area of interest for national security controls, as U.S. pharmaceutical companies have increasingly partnered with Chinese firms for development, manufacturing, and licensing arrangements. On June 8, 2026, the U.S. Department of Defense (DoD) added WuXi AppTec — a prominent Chinese drug development and manufacturing services provider — to its list of “Chinese military companies” operating in the United States.
FDA Proposes Revised Payor Communications Draft Guidance To Formally Include Devices And Reflect New Statutory Safe Harbor While Balancing Substantial Government Interests
Arnold & Porter are most popular: within Cannabis & Hemp, Media, Telecoms, IT and Entertainment topic(s) On June 3, 2026, the U.S. Food and Drug Administration (FDA or the Agency) issued a new draft guidance titled Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (the 2026 Draft Payor Guidance). Once finalized, the 2026 Draft Payor Guidance will replace the 2018 final guidance on the same topic.
FDA Advances A "Plausible Mechanism" Framework For Rare Disease Drug Development And Signals A Shift To A Single Trial With Confirmatory Evidence Default For All Drugs
AP Arnold & Porter More Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
The BIOSECURE Act Becomes Law In The United States
Arnold & Porter are most popular: with readers working within the Retail & Leisure industries On December 18, 2025, President Trump signed into law a revised version of the BIOSECURE Act (BIOSECURE or the Act) as Sec.
The BIOSECURE Act Becomes Law in the United States
On December 18, 2025, President Trump signed into law a revised version of the BIOSECURE Act (BIOSECURE or the Act) as Sec.
FDA's New "Plausible Mechanism Pathway" And Other Initiatives To Expedite Approval Of Drugs For Ultra-Rare Conditions
Arnold & Porter are most popular: within Insolvency/Bankruptcy/Re-Structuring topic(s) Rare and ultra-rare disease product developers face numerous complexities, including in designing and executing clinical trials in very small patient populations, defining and validating endpoints, satisfying the statutory evidentiary standard for product approval, and attracting investment for products with uncertain trajectories.
FDA’s New “Plausible Mechanism Pathway” and Other Initiatives To Expedite Approval of Drugs for Ultra-Rare Conditions
Rare and ultra-rare disease product developers face numerous complexities, including in designing and executing clinical trials in very small patient populations, defining and validating endpoints, satisfying the statutory evidentiary standard for product approval, and attracting investment for products with uncertain trajectories.
EXPERT INSIGHTS-FDA PROPOSES TO ELIMINATE COMPARATIVE CLINICAL EFFICIENCY STUDIES FOR BIOSIMILARS
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FDA Proposes To Eliminate Comparative Clinical Efficiency Studies For Biosimilars
Eva Temkin’s articles from Arnold & Porter are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in United States Arnold & Porter are most popular: within Insolvency/Bankruptcy/Re-Structuring topic(s) In a new draft guidance issued on October 29, 2025, the U.S. Food and Drug Administration (FDA) announced that it will drastically pare back the requirement of data from comparative clinical efficiency studies (CES) to the demonstration of biosimilarity in 351(k) biologics...
FDA Proposes To Eliminate Comparative Clinical Efficiency Studies for Biosimilars
In a new draft guidance issued on October 29, 2025, the U.S. Food and Drug Administration (FDA) announced that it will drastically pare back the requirement of data from comparative clinical efficiency studies (CES) to the demonstration of biosimilarity in 351(k) biologics license applications (BLAs).1 Now 15 years after the passage of the Biologics Price Competition and Innovation Act, which created the biosimilars pathway, FDA views such studies as, by and large, “resource-intensive” and...
DTC Reforms And MAHA Proclamations: The MAHA Agenda And Its Focus On Prescription Drugs Continues To Take Shape
The White House released the long-awaited Make America Healthy Again (MAHA) Strategy Report (the Strategy) on September 9, 2025 to much fanfare, though the report itself was rather lackluster.1 The accompanying U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) communications2 were, however, of more consequence.
DTC Reforms and MAHA Proclamations: The MAHA Agenda and Its Focus on Prescription Drugs Continues To Take Shape
The White House released the long-awaited Make America Healthy Again (MAHA) Strategy Report (the Strategy) on September 9, 2025 to much fanfare, though the report itself was rather lackluster.1 The accompanying U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) communications2 were, however, of more consequence.
EXPERT INSIGHTS-CONGRESS REVISITS THE BIOSECURE ACT: RISKS FOR BIOTECHNOLOGY COLLABORATIONS WITH CHINESE ENTITIES
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Congress Revisits The BIOSECURE Act: Risks For Biotechnology Collaborations With Chinese Entities
AP Arnold & Porter More Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
Congress Revisits the BIOSECURE Act: Risks for Biotechnology Collaborations With Chinese Entities
In the last Congress, the BIOSECURE Act (H.R. 8333, 118th) garnered significant attention despite not becoming law.
Implications Of FDA's "Radical Transparency" Plan For Complete Response Letters
The U.S. Food and Drug Administration (FDA), as part of the push towards "radical transparency" led by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., recently released 200 complete response letters (CRLs) for approved drugs and devices. The FDA also announced that the agency intends to start publishing CRLs in real time for unapproved drugs and devices.
Implications of FDA’s “Radical Transparency” Plan for Complete Response Letters
The U.S. Food and Drug Administration (FDA), as part of the push towards “radical transparency” led by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., recently released 200 complete response letters (CRLs) for approved drugs and devices. The FDA also announced that the agency intends to start publishing CRLs in real time for unapproved drugs and devices.
FDA Begins To Accept Nominations For The Commissioner's National Priority Voucher Pilot Program
The U.S. Food and Drug Administration (FDA) has released new information about the Commissioner's National Priority Voucher (CNPV) pilot program, which offers a small number of participating U.S. drug companies highly expedited (1-2 month) review of their drug or biologics marketing application and enhanced communications with the agency.1 Details surrounding CNPVs had been limited at the time of FDA's announcement last month (which we discussed in our June 2025 Advisory).
FDA Begins To Accept Nominations for the Commissioner’s National Priority Voucher Pilot Program
The U.S. Food and Drug Administration (FDA) has released new information about the Commissioner’s National Priority Voucher (CNPV) pilot program, which offers a small number of participating U.S. drug companies highly expedited (1-2 month) review of their drug or biologics marketing application and enhanced communications with the agency.1 Details surrounding CNPVs had been limited at the time of FDA’s announcement last month (which we discussed in our June 2025 Advisory).
FDA Announces Commissioner's National Priority Vouchers To Facilitate Expedited Access To Certain Drugs
On June 17, 2025, the U.S. Food and Drug Administration (FDA or the Agency) announced its new Commissioner's National Priority Voucher (CNPV) program. Under the CNPV program, FDA may grant priority review to U.S. drug companies "aligned with U.S. national priorities" that could significantly expedite access to innovative therapies.
FDA Announces Commissioner’s National Priority Vouchers To Facilitate Expedited Access To Certain Drugs
On June 17, 2025, the U.S. Food and Drug Administration (FDA or the Agency) announced its new Commissioner’s National Priority Voucher (CNPV) program. Under the CNPV program, FDA may grant priority review to U.S. drug companies “aligned with U.S. national priorities” that could significantly expedite access to innovative therapies.
AI, Medical Products & FDA, Part 1: AI Overview In Life Sciences (Podcast)
Listen on Spotify Listen on Apple Podcasts In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Dan Kracov, Partner at Arnold and Porter and Chair of the firm's Global Life Sciences Industry group; Abeba Habtemariam, Partner at Arnold & Porter; Ethan Dabbs, Managing Director and Senior Partner at the Boston Consulting Group; and Lauren Silvis, Senior Vice President of External Affairs at Tempus.
EXPERT INSIGHTS-PRESIDENT TRUMP ISSUES EXECUTIVE ORDER ON REGULATORY RELIEF TO PROMOTE DOMESTIC PRODUCTION OF CRITICAL MEDICINES
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President Trump Issues Executive Order On Regulatory Relief To Promote Domestic Production Of Critical Medicines
On May 5, 2025, President Trump signed an Executive Order entitled, "Regulatory Relief to Promote Domestic Production of Critical Medicines" (the EO), directing the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Army Corps of Engineers to assess and improve their regulations and guidance in certain areas to encourage, and to reduce "duplicative or unnecessary" barriers to, domestic pharmaceutical manufacturing.
President Trump Issues Executive Order on Regulatory Relief To Promote Domestic Production of Critical Medicines
On May 5, 2025, President Trump signed an Executive Order entitled, “Regulatory Relief to Promote Domestic Production of Critical Medicines” (the EO), directing the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Army Corps of Engineers to assess and improve their regulations and guidance in certain areas to encourage, and to reduce “duplicative or unnecessary” barriers to, domestic pharmaceutical manufacturing.
A First Look At The MAHA Era: Initial Thoughts For Industry Based On The MAHA Commission EO
Swiftly following the confirmation of Robert F. Kennedy Jr. as Secretary of the Department of Health and Human Services (HHS), the White House issued an Executive Order (EO) establishing the Make America Healthy Again (MAHA) Commission,1 whose policies and actions could reshape the life sciences industry.
The DOGE Workforce Optimization EO: Implications For FDA
The Trump administration has yet to issue anticipated U.S. Food and Drug Administration (FDA)-specific Executive Orders, but as we have previewed in other Advisories,1 the Executive Orders that have been issued may have far reaching effects on the Life Sciences Industry and drug and device manufacturers in particular.
A First Look at the MAHA Era: Initial Thoughts for Industry Based on the MAHA Commission EO | Advisories | Arnold & Porter
Swiftly following the confirmation of Robert F. Kennedy Jr. as Secretary of the Department of Health and Human Services (HHS), the White House issued an Executive Order (EO) establishing the Make America Healthy Again (MAHA) Commission,1 whose policies and actions could reshape the life sciences industry.
The DOGE Workforce Optimization EO: Implications for FDA
The Trump administration has yet to issue anticipated U.S. Food and Drug Administration (FDA)-specific Executive Orders, but as we have previewed in other Advisories,1 the Executive Orders that have been issued may have far reaching effects on the Life Sciences Industry and drug and device manufacturers in particular.
FDA Finalizes Rule On ACNU Drugs, Signaling Opening For Next-Gen OTC Drugs
UPDATE: On January 24, 2025, FDA delayed the effective date for the final rule until March 21, 2025, in accordance with the "Regulatory Freeze Pending Review" Executive Order issued on January 20, 2025. The ACNU Final Rule was originally scheduled to take effect on January 27, 2025.
FDA Finalizes Rule on ACNU Drugs, Signaling Opening for Next-Gen OTC Drugs
On December 26, 2024, the U.S. Food and Drug Administration (FDA) finalized its new rule governing approval of a Nonprescription Drug Product with an Additional Condition for Nonprescription Use (the ACNU Final Rule).1 The ACNU Final Rule, which largely hews to the proposed rule, establishes requirements for approval of over-the-counter (OTC) drug products that rely on ACNUs to ensure appropriate self-selection and/or appropriate actual use by consumers without the supervision of a healthcare...
The Convergence Of Life Sciences And Artificial Intelligence: Seizing Opportunities While Managing Risk
The rapid pace of AI implementation in life sciences requires action now to anticipate and manage risks. As best practices, applications, regulations, and risks evolve alongside AI technologies, life sciences companies will need to stay vigilant as they continue to leverage these tools across the enterprise.
Pharmaceutical Intellectual Property and Competition: Editor's Preface
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FDA Issues Revised Draft Guidance On Addressing Misinformation About Medical Devices And Prescription Drugs
On July 8, 2024, the U.S. Food and Drug Administration (FDA) issued updated draft guidance titled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers" (hereinafter "Misinformation Draft Guidance" or "draft guidance").
FDA Issues Revised Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs
On July 8, 2024, the U.S. Food and Drug Administration (FDA) issued updated draft guidance titled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (hereinafter “Misinformation Draft Guidance” or “draft guidance”).
When APA Claims Accrue Under Corner Post: Implications For The Life Sciences Industry
On July 1, 2024, the Supreme Court issued a 6-3 opinion in the case of Corner Post, Inc. v. Board of Governors of the Federal Reserve System, holding that an Administrative Procedure Act (APA) claim "accrues" when a plaintiff is injured by final agency action pursuant to the statute of limitations set forth in 28 U.S.C. § 2401(a), even when the government action being challenged occurred much earlier.
When APA Claims Accrue Under Corner Post: Implications for the Life Sciences Industry
On July 1, 2024, the Supreme Court issued a 6-3 opinion in the case of Corner Post, Inc. v. Board of Governors of the Federal Reserve System, holding that an Administrative Procedure Act (APA) claim “accrues” when a plaintiff is injured by final agency action pursuant to the statute of limitations set forth in 28 U.S.C. § 2401(a), even when the government action being challenged occurred much earlier.
Five Key Takeaways From FDA's Updated Draft Guidance On Biosimilars Promotion
On April 24, 2024, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry" (Draft Biosimilar Promotion Guidance or the Revised Draft Guidance).
Five Key Takeaways From FDA
On April 24, 2024, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry” (Draft Biosimilar Promotion Guidance or the Revised Draft Guidance).
Life Sciences 2024 - Life Sciences, Biotechnology & Nanotechnology - United States
1. Life Sciences Regulatory Framework The primary legislation governing the authorisation, marketing, sale and supply of pharmaceutical products by the US Food and Drug Administration (FDA) is the Federal Food, Drug, and Cosmetic Act (the "FD&C Act"), which has been amended many times throughout the years to reflect increasing FDA mandates for the regulation of pharmaceutical products.
Navigating The Pending BIOSECURE Act: Implications For U.S.-China Biopharmaceutical Collaboration And National Security
The BIOSECURE Act (H.R. 7085), which has the potential to severely restrict the ability of U.S. biopharmaceutical companies to collaborate with certain Chinese entities without losing the ability to contract with the U.S. government, has made headlines in recent weeks.
Navigating the Pending BIOSECURE Act: Implications for U.S.-China Biopharmaceutical Collaboration and National Security
The BIOSECURE Act (H.R. 7085), which has the potential to severely restrict the ability of U.S. biopharmaceutical companies to collaborate with certain Chinese entities without losing the ability to contract with the U.S. government, has made headlines in recent weeks.
Addressing CBRN Threats And Promoting Responsible AI In Healthcare: Insights From President Biden's AI Executive Order
In an increasingly interconnected world, the convergence of cutting-edge technologies and emerging security threats pose unique challenges that demand proactive solutions. Chemical, biological, radiological, and nuclear (CBRN) weapons have long been a cause for concern in the realm of national security. However, as technology evolves, so too does the potential for these threats to be amplified and exploited.
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