Author Info for Morgan Lewis - As Prescribed

Michael Abernathy

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify… more

Abbreviated New Drug Application (ANDA), Federal Trade Commission (FTC), Food and Drug Administration (FDA), FTC Act, Life Sciences

See all updates »

Stephen Altieri, Ph.d.

How to Develop Partner-Ready Patent Estates

For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent… more

Intellectual Property Protection, Patent Infringement, Patents, Pharmaceutical Industry, Pharmaceutical Patents

See all updates »

Michael Barron

Venture Philanthropy More Important Than Ever for Rare Disease Care

Private foundations providing support, resources, and advocacy for individuals and families affected by rare diseases have played an important role for more than 30 years in the advancement of treatments for rare diseases. Much… more

Healthcare, Internal Revenue Code (IRC), Investment, IRS, Life Sciences

See all updates »

Jacqueline Berman

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The 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… more

See all updates »

Christopher Betti, Ph.d.

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As… more

Acquisitions, Artificial Intelligence, Biologics, Biosimilars, Data Protection

See all updates »

Nikita Bhojani

FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors that… more

Biologics, Food and Drug Administration (FDA), Investigational New Drug Application (IND), Life Sciences, Manufacturers

See all updates »

Fred Block

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The 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… more

See all updates »

Michele Buenafe

DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations

The 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… more

Cybersecurity, Department of Justice (DOJ), Digital Health, Enforcement Actions, False Claims Act (FCA)

See all updates »

Laurie Burlingame

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and… more

Acquisitions, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Investors, Life Sciences

See all updates »

Emily Coury

How to Develop Partner-Ready Patent Estates

For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent… more

Intellectual Property Protection, Patent Infringement, Patents, Pharmaceutical Industry, Pharmaceutical Patents

See all updates »

Rebecca Dandeker

A Clearer Path from FDA for ‘Minor Changes’ to Solid Oral Dosage Forms for OTC Monograph Drugs

Recent 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,… more

Administrative Orders, Comment Period, Draft Guidance, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA)

See all updates »

Roshni Edalur

California’s Revised Prescription Drug Price Transparency Regulations Effective April 1

Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and notice… more

Drug Pricing, Manufacturers, Pharmaceutical Industry, Prescription Drugs, Transparency

See all updates »

Gregory Etzel

US Supreme Court Hears Oral Arguments in Challenge to Chevron Deference

The US Supreme Court recently debated the future of the legal precedent known as Chevron deference in two separate cases arising out of the National Marine Fisheries Service’s statutory interpretation of the Magnuson-Stevens… more

Chevron Deference, Loper Bright Enterprises v Raimondo, Magnuson-Stevens Act (MSA), National Marine Fisheries Service, Oral Argument

See all updates »

J. Clayton Everett, Jr.

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify… more

Abbreviated New Drug Application (ANDA), Federal Trade Commission (FTC), Food and Drug Administration (FDA), FTC Act, Life Sciences

See all updates »

R. Brendan Fee

FTC Policy Statement on Orange Book Listings Brings More Clarity (Sort Of)

With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration… more

Competition, Federal Trade Commission (FTC), Food and Drug Administration (FDA), FTC Act, Life Sciences

See all updates »

Suzanne Filippi

Prep Pitch and Connect at the JP Morgan Healthcare Conference

As the healthcare and life sciences industry gears up for the highly anticipated JP Morgan Healthcare Conference later this month, stakeholders across the sector are focusing on key trends and strategies to make the most of this… more

Acquisitions, Artificial Intelligence, Biotechnology, Healthcare, Investment

See all updates »

Sophia Gaulkin

FDA Issues MAPP for Reviewing Color Additives and Flavors in Oral Drug Products

FDA’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) in June explaining the agency’s internal procedures for evaluating color additives and flavors in an oral drug product submitted… more

Code of Federal Regulations (CFR), Food and Drug Administration (FDA), Generic Drugs, GRAS, Life Sciences

See all updates »

David Glazer

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The 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… more

See all updates »

Luciana Griebel

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and… more

Acquisitions, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Investors, Life Sciences

See all updates »

Jacob Harper

Congress Temporarily Extends Hospice Telehealth Face-to-Face Flexibility

US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also extended… more

Health Care Providers, Hospice, Physicians, Telehealth

See all updates »

Alexander Hastings

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical… more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

See all updates »

Katelyn Hilferty

Bipartisan Drug Pricing Reform: The FPDP Act and Revival of Most-Favored-Nation Pricing

As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription… more

Department of Health and Human Services (HHS), Drug Pricing, Executive Orders, Medicaid, Medicare

See all updates »

Owen Hosseinzadeh

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

On 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… more

Administrative Procedure Act, Biologics, Center for Biologics Evaluation and Research (CBER), Enforcement Actions, Federal Food Drug and Cosmetic Act (FFDCA)

See all updates »

Zachary Johns

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,”… more

AMG Capital Management LLC v FTC, Antitrust Violations, Biosimilars, Competition, Exclusive Licenses

See all updates »

Maarika Kimbrell

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

On 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… more

Administrative Procedure Act, Biologics, Center for Biologics Evaluation and Research (CBER), Enforcement Actions, Federal Food Drug and Cosmetic Act (FFDCA)

See all updates »

Rachel Lamparelli

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

The 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… more

Biotechnology, Clinical Trials, Drug Approvals, Drug Pricing, Inflation Reduction Act (IRA)

See all updates »

Alan Leeds

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical… more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

See all updates »

B. Scott McBride

DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations

The 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… more

Cybersecurity, Department of Justice (DOJ), Digital Health, Enforcement Actions, False Claims Act (FCA)

See all updates »

William Mcenroe

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,”… more

AMG Capital Management LLC v FTC, Antitrust Violations, Biosimilars, Competition, Exclusive Licenses

See all updates »

Scott Memmott

DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations

The 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… more

Cybersecurity, Department of Justice (DOJ), Digital Health, Enforcement Actions, False Claims Act (FCA)

See all updates »

Sydney Menack

A Clearer Path from FDA for ‘Minor Changes’ to Solid Oral Dosage Forms for OTC Monograph Drugs

Recent 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,… more

Administrative Orders, Comment Period, Draft Guidance, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA)

See all updates »

Benjamin Pensak

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As… more

Acquisitions, Artificial Intelligence, Biologics, Biosimilars, Data Protection

See all updates »

Paul Ranson

New Measures to Encourage Clinical Trials in the United Kingdom

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK clinical… more

Clinical Trials, EU, Life Sciences, New Legislation, Pharmaceutical Industry

See all updates »

Amanda Robinson

Bipartisan Drug Pricing Reform: The FPDP Act and Revival of Most-Favored-Nation Pricing

As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription… more

Department of Health and Human Services (HHS), Drug Pricing, Executive Orders, Medicaid, Medicare

See all updates »

Kathleen Sanzo

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

The 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… more

Biotechnology, Clinical Trials, Drug Approvals, Drug Pricing, Inflation Reduction Act (IRA)

See all updates »

Ariel Seeley

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an… more

Algorithms, Artificial Intelligence, Draft Guidance, Food and Drug Administration (FDA), Machine Learning

See all updates »

Angela Silva

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and leverages… more

Artificial Intelligence, Draft Guidance, Food and Drug Administration (FDA), Machine Learning, Medical Devices

See all updates »

Nathan Smith

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical… more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

See all updates »

Robert Smyth, Ph.d.

Bipartisan Focus on Drug Prices Continues with Proposed Expansion of Federal Authority Over Patent Rights

Pharmaceutical drug pricing and reimbursement remains a bipartisan focus as we draw closer to the November presidential elections, with politicians remaining steadfast in their efforts to turn up the heat on pharmaceutical… more

Drug Pricing, Intellectual Property Protection, NIST, Patents, Pharmaceutical Industry

See all updates »

Benjamin Stein

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As… more

Acquisitions, Artificial Intelligence, Biologics, Biosimilars, Data Protection

See all updates »

Carolyn Welshhans

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The 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… more

See all updates »

Tesch Leigh West

Unpackaging CMS’s HOPPS Proposed Rule and Payments for Diagnostic Radiopharmaceuticals

In what can only be characterized as a necessary but significant proposed departure from current political initiatives focused on lowering pharmaceutical drug prices, the Centers for Medicare & Medicaid Services (CMS) proposes… more

Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Medicare, Medicare Part B, Pharmaceutical Industry

See all updates »

Jonathan York

DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations

The 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… more

Cybersecurity, Department of Justice (DOJ), Digital Health, Enforcement Actions, False Claims Act (FCA)

See all updates »

Howard Young

Congress Temporarily Extends Hospice Telehealth Face-to-Face Flexibility

US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also extended… more

Health Care Providers, Hospice, Physicians, Telehealth

See all updates »

Dennie Zastrow

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,”… more

AMG Capital Management LLC v FTC, Antitrust Violations, Biosimilars, Competition, Exclusive Licenses

See all updates »

Morgan Lewis - As Prescribed

"My best business intelligence, in one easy email…"

"My best business intelligence,
in one easy email…"