Morgan Lewis

FDA/Healthcare Regulation

Publications of Interest

150 Publications Found
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09/13/07 Advancing European Medtech: A Regulatory Perspective, presented at the MedTech Investing Europe 2007 Conference, London

Presentation | Speech
Anthony Warnock-Smith

2007 The Self-Regulation of Medicines in the UK, The International Comparative Legal Guide to: Pharmaceutical Advertising 2007

Outside Publications | Article
Anthony Warnock-Smith, Natalie Kingston

July 2007 Medicare Reimbursement in Clinical Trials for “Standard of Care” in Flux

White Paper | Morgan Lewis White Paper
FDA/Healthcare Regulation

It may no longer be possible to take for granted that Medicare will pay for standard of care treatment in the clinical trial setting. "Standard of care" services are generally understood to be those services th... more

07/25/07 Medicare Reimbursement for “Standard of Care” in Flux

LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA/Healthcare Regulation

Medicare has proposed new rules as to when reimbursement is available for standard of care treatment furnished to clinical research subjects. “Standard of care” services are generally understood to be those ser... more

07/18/07 CMS Proposes Changes to Its Policies Governing Off-Label Uses of Anticancer Drugs and Biologicals

LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA/Healthcare Regulation

A recently issued proposed change to Medicare policy could significantly affect Medicare payment for anticancer drugs and biologicals. The Centers for Medicare and Medicaid Services (CMS) has proposed a laundry... more

06/29/07 FDA Regulation of Medical Devices, presented at the D.C. Bar Health Law Section and Litigation Section Off-The-Record Luncheon Program, Washington, D.C.

Presentation | Speech
Phoebe Mounts

06/28/07 Final Rule for Dietary Supplement GMPs

LawFlash/Client Alert | FDA-Healthcare Regulation LawFlash
FDA/Healthcare Regulation

On June 25, the FDA issued the long-awaited good manufacturing practice (GMP) requirements for dietary supplements. The final regulation applies to all firms that manufacture, package, label, or hold dietary su... more

06/19/07 Proactive Steps Every Provider Should Take to Avoid Government Scrutiny, presented at ACI's Preparing for Government Healthcare Fraud Enforcement Conference, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

06/18/07 New Risks, New Plan: Drug Safety Concerns Show Need for Sophisticated Risk Management, Legal Times, Vol. 30, No. 25

Outside Publications | Article
Stephen Mahinka, Kathleen Sanzo

05/17/07 Compliant Models for Medical Device Grants, presented at CBI's Premier West Coast Conference on Bio/Pharmaceutical and Medical Device Grants, San Francisco

Presentation | Speech
Kathleen Sanzo

05/17/07 Regulatory and Corporate Considerations in Life Sciences Industry Investments, presented at a Morgan Lewis Seminar, Palo Alto

Presentation | Speech
Kathleen Sanzo, Denis Segota

04/26/07 Sailing to FDA Product Approval: Innovations in the Clinical Trial Paradigm, presented at Bay Bio 2007, San Francisco

Presentation | Speech
Phoebe Mounts

04/17/07 Managing Customer Communications in a Post-Neurontin World, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
M. Elizabeth Bierman

04/17/07 The AdvaMed Code of Ethics, presented at the AdvaMed MTLI Conference: The Regulation of Advertising, Promotion, and Sales of Medical Devices, Washington, D.C.

Presentation | Speech
Kathleen Sanzo

03/22/07 The Patient's Nose Under the Tent: The Impact on Hospitals of State and Federal Healthcare Transparency Initiatives, presented at the American Health Lawyers Association's Institute on Medicare and Medicaid Payment Issues, Baltimore

Presentation | Speech
Andrew Ruskin

03/21/07 2006: The RAP Practice Group's Year in Review, presented at the American Health Lawyers Association's Institute on Medicare and Medicaid Payment Issues, Baltimore

Presentation | Speech
Andrew Ruskin

03/02/07 Potential Challenges to Pricing of Biotech Products: Medicare/Medicaid and Related Pricing Developments, presented at the 2007 BIO General Counsels' Committee Meeting

Presentation | Speech
Stephen Mahinka, Andrew Ruskin

2007 Keys to Successful Interactions with Governing Bodies, Inside the Minds: Food and Drug Law Settlements and Negotiations

Outside Publications | Article
Kathleen Sanzo

January 2007 The New Congress: Outlook for Health Care Legislation in 2007, presented at the Fulbright & Jaworski Health Law Teleconference, Washington, D.C.

Presentation | Speech
Anne Sullivan

October 2006 Navigating the Road Ahead: E-Discovery and Information Management Workshop, presented at Fulbright & Jaworski, LLP, Washington, D.C.

Presentation | Speech
Anne Sullivan

08/24/06 Risk Management Strategy for the Pharma and Biotech Product Lifecycle: New Regulatory and Legal Focus and Approach, presented at the 2nd Annual FDA Regulatory and Compliance Symposium, Harvard University, Cambridge, MA

Presentation | Speech
Stephen Mahinka

07/18/06 Crossing Paths with the FDA—Regulatory Influence on the Defense of Drug and Device Products, presented at the Defense Research Institute Teleconference

Presentation | Speech
Kathleen Sanzo

May 2006 DRA May Drive New Relationships, Reimbursement Advisor, Vol. 21, No. 10

Outside Publications | Article
Andrew Ruskin

May 2006 E-Health Initiatives and Federal Legislation, presented at the Greater Washington, D.C. Chapter of ARMA's Annual Seminar, Washington, D.C.

Presentation | Speech
Anne Sullivan

May 2006 Medicare Inpatient Prospective Payment System Proposed Rule for 2007, presented at the Fulbright & Jaworski Health Conference, Washington, D.C.

Presentation | Speech
Anne Sullivan

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