21st Century Cures Act

Recorded December 21, 2016 | On-Demand Webinar

The 21^st Century Cures Act—signed into law by the President on Tuesday, December 13, is sweeping bipartisan legislation intended to advance the research and development of new therapies and diagnostics and that makes substantial federal investments in a wide range of health care priorities. The Act’s changes to the Federal Food, Drug, and Cosmetic Act are significant, clarifying and creating new FDA authorities over drugs, including regenerative advanced therapies; medical devices, including certain health software; and combination products; as well as FDA’s administrative authorities. Join FDLI for an overview of the FDA-related sections of this new law while hearing directly from those intimately involved in the legislation.

Eva Temkin, Counselor, Office of the Chief Counsel, FDA
Wade Ackerman, Partner, Covington & Burling LLP
Marcy Busch, Counselor, Office of Chief Counsel, FDA
Moderated by Carla Cartwright, Director, Global Regulatory Policy & Intelligence, Janssen Pharmaceuticals Inc.

Get Access

$99

+$100 for non-members

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Virtual Learning FAQ

When will I receive my session?

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.

Is my computer/mobile device compatible?

On-demand content can be played back on most devices.

Is CLE credit available?

CLE credit is not currently available for pre-recorded sessions.

Related Content

Essential Vaccine Policy Updates: ACIP, CDC’s COVID-19 Guidance, and What’s Next

FDA and Medical Product Oversight: Assessing Recent Changes

The MAHA Agenda: Implications for Drug Pricing Reform

Tariff Shake-Up: The Impact on Drug and Device Access, Costs, and Manufacturing

Cosmetics and Children: Safety, Advertising, and Enforcement in the Era of Viral Products

Risky Business: Addressing 2025 Drug and Device Inspections

The Results Are In: How the 2024 Election Outcomes Will Impact Healthcare Policies

An Introduction to Drug Enforcement: FDA Enforcement Authorities, Tools, Violations and Initiatives

Regulation of Drug Marketing: An Introduction

Regulation of Drug Manufacturing: An Introduction

Regulation of Over-the-Counter (OTC) Drugs: An Introduction

The Regulation of Biologics and Biosimilars: An Introduction

Post Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes

An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

The New Drug Approval Process: NDA Submission and Review

The New Drug Approval Process: New Drug Research and Development

The New Drug Approval Process: Basic Concepts

Origins and Overview of Drug Law Regulation: An Introduction

Stabilizing After the Stabilization Period: What to Expect From Further Implementation of DSCSA

International Issues for Medical Device Manufacturers: An Introduction

An Introduction to the Regulation of Promotion and Advertising for Medical Devices

FDA Authorities and Processes for the Enforcement, Compliance, and Inspection of Medical Devices

Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction

Post Marketing Issues for Medical Devices: An Introduction

An Introduction to Coverage, Coding, and Payment of Medical Devices – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

Medical Device Premarket Approval Applications (PMA); Humanitarian Device Exemption (HDE) and Breakthrough Devices: An Introduction

An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests

Medical Device Clinical Investigations: An Introduction

Regulation of Digital Health Products: An Introduction

An Introduction to the Regulation of Combination Products for Medical Devices

Overview of Medical Device Law and Regulation

Hatch–Waxman at 40: A Critical Examination of its Past and Future

Advancing the Mission: Former FDA Chief Counsels on FDLI’s Future as a Resource for the Bar

The Fate of FDA Authority: Addressing Recent Supreme Court Decisions on Mifepristone, Chevron, and Beyond

High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling

Decoding FDA’s New Rule on LDTs: Insights, Implications, and Legislative Considerations

Veterinary Products Caselaw and Emerging Trends: An Introduction

An Introduction to Animal Food, Feed, and Supplements Requirements and Challenges

An Introduction to Veterinary Drug and Device Requirements and Challenges

Veterinary Product Regulation: An Introduction to the Roles and Responsibilities of FDA and USDA

Veterinary Products: An Introduction to the Federal Regulatory Landscape

An Introduction to Laws Governing Veterinary Products

Social Media Spotlight: FDA Compliance for TikTok, X, LinkedIn, and Other Content

Cosmetic Safety and Contaminants: PFAS, State Versus Federal Regulation, and More

An Introduction to Violations, Enforcement, and International Issues in Biologics and Biosimilars

The Regulation of Biological Product Marketing: An Introduction

The Regulation of Biological Product Manufacturing: An Introduction

Post-Approval Pharmacovigilance of Biological Products: An Introduction

Biologics and Biosimilars: An Introduction

Biological Product Approval, Vaccines, Emergency Use Authorization: An Introduction

Introduction to Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy

Regulation of Biological Product/Drug Development: An Introduction

Introduction to FDA Review and Approval of Biological Products

Overview of Biological Products Law and FDA’s Regulatory Processes

USPTO-FDA Collaboration: Progress Towards Patently True Interagency Coordination

Collaboration Across Agencies: Understanding the Role of FDA, USDA, and EPA in Food Regulation

Recent Rulings on Mifepristone Access: Implications for FDA and Stakeholders

Meet MoCRA: Getting to Know the Modernization of Cosmetics Regulation Act

Psychedelics Meet Mainstream Medicine: Overcoming Regulatory Uncertainty and Addressing Patient Safety Challenges

The Drug Supply Chain Security Act: Implementation Challenges, Industry Compliance, and Best Practices

Implementation of the Inflation Reduction Act: Healthcare Reform and Implications for the Pharmaceutical Industry

Fundamentals of FDA Regulation of Cosmetics

FDLI Book Launch—How FDA Really Works: Insights from the Experts

Supply Chain Mayhem: Industry Impacts and What Can be Done

Updates and Developments in Drug Compounding

Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution

Essentials of Inspection Readiness for Medical Products

Essentials of FDA, DOJ, FTC Enforcement Authorities

You Can’t Outsource Responsibility: Managing Quality in a Contract Manufacturing Partnership

Over-the-Counter Drugs Monograph Reform – How’s it Going?

FDA’s COVID-19 Activities

FDA’s Expedited Programs: Understanding Which Program Best Suits Your Product

The Promise and Problem of Blockchain for Medical Products: What Lawyers Need to Know

Understanding Synthetic Nicotine: A Comprehensive Scientific and Legal Review

Navigating the Complexities of Combination Product Regulation

Medical Device Clinical Investigations: An Introduction to Sponsor Responsibilities and Compliance Issues

Medical Device Manufacturer Requirements: An Introduction to Registration and Listing of Establishments

FDA and Centers for Medicare and Medicaid Services: Regulatory Considerations for Communicating and Contracting for Value

Best Practices for Drug Recalls

The Essentials of Food Science

Machine Learning for Regulatory Attorneys and English Majors

The Essentials of Statistics for Medical Products Lawyers

The Essentials of Clinical Trial Science

How Does FDA’s Recent Guidance on Remote Interactive Evaluations Change the Inspections Landscape?

Biologic and Biosimilar Litigation and IP Rights

The Impact of COVID-19 on the In Vitro Diagnostic Industry

Biosimilars: Regulatory Challenges and Barriers to Entry

Examining the State of Drug Importation and Drug Pricing

FDA’s Legal Authority Over Laboratory Developed Tests

Compounding Drug Products Due to Supply Chain Access in Light of COVID-19

FDA’s Compounding Memorandum of Understanding with States: Questions, Concerns, and What’s Next

Continued Reliance on Foreign Drug Manufacturing and the Drug Supply Chain: Manageable Risk or Public Health Concern?

State of FDA Medical Product Manufacturer Inspections During and After COVID-19

Restarting Clinical Trials in the Wake of COVID-19

Animal Drug Compounding: FDA’s New Guidance and Impacts on Industry

COVID-19 and Beyond: Development and Implementation of Recovery Action Plans for Medical Product Manufacturers

The Long-Awaited Biologics Transition Date Has Come: What Now?

FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products

What are FDA’s Tools for Responding to Public Health Emergencies Such as the Coronavirus (COVID-19)?

The CREATES Act Has Passed: What Does It Mean for the Generics Industry?

Reducing Anti-Kickback Risks Associated with Medical Products

Introduction to Product Liability Regarding FDA-Regulated Products

Due Diligence: Ensuring Your Deal Doesn’t Collapse Due to Regulatory, Clinical, Quality, or Data Integrity Issues

Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges

New Management Standards for Hazardous Waste Pharmaceuticals and Nicotine

Patient Assistance Programs: Recent Enforcement and Best Practices

Opioid Legislation: The Path Forward for FDA and DEA Webinar

From Approval to Coverage – FDA and CMS Jurisdictional Lines

Drug Pricing for the Food and Drug Community

Organic Chemistry for the Food and Drug Community

DEA Law for the Food and Drug Community

Data Integrity: FDA Enforcement and Risk-Reduction Considerations

New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

Real World Evidence: Data Requirements, Utilization, and Presentation

Development of Medical Devices: Best Practices for Safeguarding Your IP and FDA Rights

PDUFA and BsUFA Reauthorization: Key Changes Affecting Industry and Patients

The EU’s New Medical Device and IVD Regulations

REMS: Key Issues and Best Practices

Compounding Still in the Mix: Title I of the DQSA, the Compounding Quality Act, Three Years Later

Recent FDA Guidance Documents on Manufacturer Communications about Medical Products

21st Century Cures Act

Open Payments Data and the Sunshine Act: Managing the Risk of Transparency

admin2024-07-19T09:30:41-04:00