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Articles by James Ravitz
Health Law Daily Wrap Up , EXPERT INSIGHTS—Peptides First, Paperwork Later: HHS Clears Six For Compounding Ahead Of Bulks List Rulemaking , (Nov 4, 2026)
Articles Law Firms Organizations Law Firms Mentioned:McDermott Will & Schulte By Monica R. Chmielewski, Kyle Y. Faget, Patrick Zanayed, Emica Kim, Jae Hyun Lee, Grayson I. Dimick, Marshall E.
Peptides first, paperwork later: HHS clears six for compounding ahead of Bulks List rulemaking
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Peptides first, paperwork later: HHS clears six for compounding ahead of Bulks List rulemaking
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Peptides first, paperwork later: HHS clears six for compounding ahead of Bulks List rulemaking
We've updated our Privacy Statement. Before you continue, please read our new Privacy Statement and familiarize yourself with the terms.
Federal Regulators And State Boards Crack Down On RUO Peptides
In the past few weeks, the US Food and Drug Administration (FDA) issued warning letters to various online sellers of compounded peptides, including ipamorelin, tesamorelin, and glucagon-like peptide-1s (GLP-1s). The FDA warning letters did not reference any of the six peptides that FDA’s Pharmacy Compounding Advisory Committee recommended for inclusion on the 503A Bulk Drugs List.
Federal regulators and state boards crack down on RUO peptides | JD Supra
In the past few weeks, the US Food and Drug Administration (FDA) issued warning letters to various online sellers of compounded peptides, including ipamorelin, tesamorelin, and glucagon-like peptide-1s (GLP-1s). The FDA warning letters did not reference any of the six peptides that FDA's Pharmacy Compounding Advisory Committee recommended for inclusion on the 503A Bulk Drugs List.
A New Prescription For FDA Leadership: Dr. Heidi Overton Tapped As Commissioner
On August 19, 2026, US President Donald Trump announced that he will nominate Dr. Heidi Overton to serve as the next commissioner of the US Food and Drug Administration (FDA). The announcement came three months after former Commissioner Martin A. Makary resigned in May 2026. Kyle Diamantas, FDA’s deputy commissioner for food, has served as acting commissioner since Makary’s departure. Overton currently serves as deputy assistant to the president for domestic policy.
RAPID Pathway Speeds Coverage But Raises Evidentiary Stakes
McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare, Life Sciences, Consumer Protection and Wealth Management topic(s) in United States with readers working within the Banking & Credit industries On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the US Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for certain FDA-designated Breakthrough Devices.
Getting Form 483 Responses Right: FDA’s March 2026 Draft Guidance Explained
James Ravitz’s articles from McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in Canada with readers working within the Retail & Leisure industries McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare, Life Sciences, Consumer Protection and Wealth Management topic(s) In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers...
Getting Form 483 responses right: FDA's March 2026 draft guidance explained
In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to inspectional observations issued at the conclusion of a...
EXPERT INSIGHTS-BIOSECURE AND THE SHIFT TO SECURE BIOTECH SUPPLY CHAINS
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BIOSECURE And The Shift To Secure Biotech Supply Chains
James Ravitz’s articles from McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in United States with readers working within the Banking & Credit and Retail & Leisure industries McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare, Life Sciences, Cannabis & Hemp and Privacy topic(s) The BIOSECURE Act, enacted on December 18, 2025, introduces new parameters for biotechnology companies seeking US government funding and...
FDA Proposes New Evidence Playbook For Individualized Therapies
James Ravitz’s articles from McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in United Kingdom with readers working within the Banking & Credit and Retail & Leisure industries McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare, Life Sciences, Privacy and Cannabis & Hemp topic(s) On February 23, 2026, the US Food and Drug Administration (FDA) released draft guidance outlining a new "plausible mechanism framework" that...
BIOSECURE and the shift to secure biotech supply chains
The BIOSECURE Act, enacted on December 18, 2025, introduces new parameters for biotechnology companies seeking US government funding and procurement. Although framed as a national security measure, BIOSECURE underscores how biotechnology supply chains, genomic data, and advanced manufacturing have come to be seen as strategic infrastructure.
FDA proposes new evidence playbook for individualized therapies
On February 23, 2026, the US Food and Drug Administration (FDA) released draft guidance outlining a new "plausible mechanism framework" that offers sponsors of certain individualized rare disease treatments an alternative way to demonstrate safety...
FDA's Makary Declares Upcoming Crackdown On GLP-1 Claims, Importation
James Ravitz’s articles from McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in United States with readers working within the Retail & Leisure industries McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare, Life Sciences, Cannabis & Hemp and Privacy topic(s) On February 6, 2026, the US Food and Drug Administration (FDA) announced its intent to take action against compounded GLP-1 medications.
FDA's Makary declares upcoming crackdown on GLP-1 claims, importation
On February 6, 2026, the US Food and Drug Administration (FDA) announced its intent to take action against compounded GLP-1 medications. The statement noted that FDA intends to take decisive steps to restrict the GLP-1 active pharmaceutical...
AdvaMed Modernizes Its Code Of Ethics For The Digital Era
James A. Cannatti III’s articles from McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in United States McDermott Will & Schulte are most popular: within Food, Drugs, Healthcare, Life Sciences, Cannabis & Hemp and Privacy topic(s) The Advanced Medical Technology Association (AdvaMed) announced its updated Code of Ethics on Interactions with US Health Care Professionals on October 6, 2025.
ASP Reporting Gets A Major Update In The CY 2026 PFS
Drug manufacturers, group purchasing organizations, and other companies in the drug distribution chain will be impacted by the changes to average sales price (ASP) and bona fide service fees (BFSFs) adopted by the Centers for Medicare & Medicaid Services (CMS) in the 2026 Medicare Physician Fee Schedule (PFS) final rule. The rule included multiple refinements to Medicare Part B drug reimbursement methodologies and government-price reporting obligations for manufacturers.
Rolling Forward: Cannabis Reform Takes A New Turn
Federal cannabis policy is entering a new phase. The Trump administration's executive order to reclassify marijuana under the Controlled Substances Act (CSA) marks a historic shift with broad implications for compliance, research, and business strategy. While implementation details remain uncertain, stakeholders should prepare for evolving federal requirements.
TEMPO Pilot Enrollment Begins: The Race For Digital Health Access Is On
On January 2, 2026, the US Food and Drug Administration (FDA) began accepting statements of interest for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, a program designed to accelerate access to digital health devices while maintaining patient safety. The initiative reflects FDA's evolving approach to digital health oversight, favoring flexibility and real-world evidence over traditional premarket review.
GLP-1 Coverage Expansion Under Medicare: What Digital Health Companies Need To Know
The Trump administration has announced a pricing initiative designed to reduce the cost of glucagon-like peptide-1 (GLP-1) drug products for certain Medicare enrollees. This policy represents a significant departure from the administration's prior position that Medicare and Medicaid would not cover anti-obesity medications, including GLP-1 products. The change is expected to influence market dynamics for both consumers and industry stakeholders, particularly telehealth companies.
EXPERT INSIGHTS: FDA LOOSENS THE REINS: NEW AI AND WEARABLES GUIDANCE
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FDA Loosens The Reins: New AI And Wearables Guidance
On January 6, 2026, the US Food and Drug Administration (FDA) released updates to two guidance documents reflecting a move towards a more hands-off approach to digital health product regulation. Both updated guidance documents allow for more technologies to be commercialized without FDA premarket review.
ASP reporting gets a major update in the CY 2026 PFS | JD Supra
Drug manufacturers, group purchasing organizations, and other companies in the drug distribution chain will be impacted by the changes to average sales price (ASP) and bona fide service fees (BFSFs) adopted by the Centers for Medicare & Medicaid Services (CMS) in the 2026 Medicare Physician Fee Schedule (PFS) final rule. The rule included multiple refinements to Medicare Part B drug reimbursement methodologies and government-price reporting obligations for manufacturers.
The GLP-1 effect: Innovative care delivery models and compliant disease management
GLP-1 therapies are transforming obesity and chronic disease treatment, yet navigating their complex regulatory landscape remains critical. From the Food and Drug Administration’s ‘Green List’ to state-specific rules, compliance isn’t optional – it’s a strategic advantage.
A need for speed: FDA piloting voucher program to expedite drug review | JD Supra
On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot.
Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process | JD Supra
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new dietary ingredient notification (NDIN) process. These materials aim to assist the dietary supplement industry in correctly preparing and submitting NDINs for FDA approval and highlight common issues in the NDIN submission process.
FDA teases faster approval times with new agency-wide AI tool | JD Supra
The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s launch states that FDA is already using the tool to accelerate clinical protocol reviews, speed up scientific evaluations, support safety profile assessments, and identify high-priority inspection targets.
Navigating Political Waves and Policy Shifts - European Health & Life Sciences Symposium 2025 | JD Supra
In April, McDermott gathered more than 100 health and life sciences innovators, investors, business leaders and advisers in Paris for our annual European Health & Life Sciences symposium. With such an esteemed crowd available to share insights and expertise, we took the opportunity to consider some of the more recent developments in US government policy and how political shifts on healthcare policy might impact the sector in the years to come.
Federal Court Strikes Down LDT Final Rule | JD Supra
On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests (LDTs) as medical devices on May 6, 2025. In Depth Key takeaways from the court’s ruling include the following: The court struck down the LDT final rule because it exceeded FDA’s authority under the Food, Drug, and Cosmetic Act (FDCA).
Will It (Puff, Puff) Pass? Cannabis Reform Under the Trump Administration
The Trump administration’s approach to cannabis reform will significantly impact the industry. As the proposed rulemaking to reschedule cannabis unfolds and nominees to critical agencies are confirmed, it is crucial for stakeholders to stay informed about these pivotal changes. This article provides an in-depth analysis of the implications of these developments.
Semaglutide Shortage Resolved
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the drug.
FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (draft AI-enabled device guidance) and Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (draft AI drug guidance).
Preparing for 2025: Key Trends in FDA Guidance Agendas
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities, suggesting where industry stakeholders might encounter new oversight-related opportunities and challenges in the coming year. These guidance agendas are not set in stone, however.
FDA Relaxes on Use of Scientific Info in Off-Label Communications | JD Supra
Overview On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance finalizes FDA’s revised draft guidance issued in October 2023 concerning firm-initiated communications of scientific information on unapproved uses (SIUU) of approved or cleared medical products to healthcare...
FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance finalizes FDA’s revised draft guidance issued in October 2023 concerning firm-initiated communications of scientific information on unapproved uses (SIUU) of approved or cleared medical products to healthcare providers...
End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists | JD Supra
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies.
EXPERT INSIGHTS-FDA'S FRESH TAKE ON USE OF HEALTHY IN FOOD LABELING
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FDA's Fresh Take On Use Of "Healthy" In Food Labeling
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled "Food Labeling: Nutrient Content Claims; Definition of Term 'Healthy.'" The rule revises regulations that govern when food products may be labeled as "healthy" and when a derivative term (e.g., "health," "healthful," or "healthier") may be used to make a claim about the product's nutritional content.
Tirzepatide Shortage Resolved
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the drug. An end to the shortage has important implications for industry stakeholders at various points in the medication’s supply chain. Compounding pharmacies and providers should be aware of the impact this change in shortage status has on their operations.
FDA Updates Status of GLP-1 Medications: Shortage Ends
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list.
Tirzepatide Shortage Resolved
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the drug. An end to the shortage has important implications for industry stakeholders at various points in the medication’s supply chain. Compounding pharmacies and providers should be aware of the impact this change in shortage status has on their operations.
Weight Loss Drug Shortages Will End Soon
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA's shortage list.
Weight Loss Drug Shortages Will End Soon | JD Supra
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list.
EXPERT INSIGHTS-FDA PUSHES TO DIVERSIFY CLINICAL STUDIES, RELEASES DRAFT INDUSTRY GUIDANCE
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FDA Pushes To Diversify Clinical Studies, Releases Draft Industry Guidance
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance describes which clinical studies would require diversity action plans, what clinical study sponsors should include in their plans, and when FDA may determine that a sponsor can waive the diversity action plan requirement.
FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance
FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in study populations.
Mississippi Gaming Commission Holds Monthly Meeting, Posts Report
Skip to main content August 16, 2024 Volume XIV, Number 229 Legal Analysis. Expertly Written. Quickly Found. Trending News Mississippi Gaming Commission Meeting Report (August 2024) Print Mail Download />i Facebook Twitter Linkedin Pinterest Reddit Facebook Messenger Email Digg Print X Buffer Flipboard The Mississippi Gaming Commission held its regular monthly meeting on Thursday, August 15, 2024, at 9:00 a.m. at the Jackson office.
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