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Firm Profile: Morgan Lewis
1701 Market Street
Philadelphia, PA 19103-2921, United States
Phone: 215.963.5000
Fax: 215.963.5001
Areas Of Practice
  • Health
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Other U.S. Locations
  • California
  • D.C.
  • Delaware
  • Florida
  • Illinois
  • Massachusetts
  • New Jersey
  • New York
  • Pennsylvania
  • Texas
Other Countries
  • Belgium
  • China
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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 »

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 »

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 »

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

Biosimilars, Disclosure Requirements, FDA Approval, Food and Drug Administration (FDA), Pharmaceutical Industry

See all updates »

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 »

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance…more

Coronavirus/COVID-19, Drug Pricing, Executive Orders, Food and Drug Administration (FDA), Generic Drugs

See all updates »

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

Biosimilars, Disclosure Requirements, FDA Approval, Food and Drug Administration (FDA), Pharmaceutical Industry

See all updates »

Distribution Chain Compliance for Medical Devices

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding requirements for device distribution…more

Distributors, Food and Drug Administration (FDA), Manufacturers, Medical Devices, Regulatory Oversight

See all updates »

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 »

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 »

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance…more

Coronavirus/COVID-19, Drug Pricing, Executive Orders, Food and Drug Administration (FDA), Generic Drugs

See all updates »

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 »

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 »

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 »

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 »

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 »

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 »

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

Biosimilars, Disclosure Requirements, FDA Approval, Food and Drug Administration (FDA), Pharmaceutical Industry

See all updates »

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 »

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 »

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 »

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 »

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 »

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

Biosimilars, Disclosure Requirements, FDA Approval, Food and Drug Administration (FDA), Pharmaceutical Industry

See all updates »

340B Under the Microscope: Key Trends and Takeaways for 2025

The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves,…more

Department of Health and Human Services (HHS), Drug Pricing, Hospitals, Pharmaceutical Industry, Pharmacies

See all updates »

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug…more

Comment Period, Draft Guidance, Food and Drug Administration (FDA), Food Safety, New Guidance

See all updates »

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 »

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 »

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose…more

Enforcement Actions, False Claims Act (FCA), Health Insurance, Medicare, OIG

See all updates »

340B Under the Microscope: Key Trends and Takeaways for 2025

The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves,…more

Department of Health and Human Services (HHS), Drug Pricing, Hospitals, Pharmaceutical Industry, Pharmacies

See all updates »

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 »

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 »

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 »

From Prohibition to Prescription: DEA Issues Proposed Rule to Reschedule Marijuana

On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). This…more

Controlled Substances Act, DEA, Department of Health and Human Services (HHS), Marijuana, Medical Marijuana

See all updates »

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 »

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 »

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 »

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 »

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 »

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

Biosimilars, Disclosure Requirements, FDA Approval, Food and Drug Administration (FDA), Pharmaceutical Industry

See all updates »

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 »

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose…more

Enforcement Actions, False Claims Act (FCA), Health Insurance, Medicare, OIG

See all updates »

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 »

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 »

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