become a member

Regulation of Biological Product/Drug Development: An Introduction

Summarize preclinical and clinical testing, sources of Good Clinical Practice (GCP) requirements and phases of the clinical trial process. Identify the obligations of sponsors and investigators. Learn about interacting with FDA during product development. Understand compliance and enforcement considerations for development programs.

Natasha V. Leskovsek, Of Counsel, Cooley LLP

This session was recorded as part of FDLI’s Introduction to Biologics: Vaccines, Biosimilars, Cell and Gene Therapies, and More Course in March 2024.

Get Access

$149

+$100 for nonmembers

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

Food and Dietary Supplement Imports and International Issues: An Introduction

FDA Inspection and Enforcement Authority for Food and Dietary Supplement Manufacturers

Food Advertising: An Introduction to the Federal Trade Commission and Private Rights of Action

Food Labeling: An Introduction to Nutrient Content, Health, and Other Claims

Food Labeling: An Introduction to General Requirements (Including Meat and Poultry)

The Regulation of Dietary Supplements: An Introduction

Foods Developed Using Biotechnology and Animal Cell Culture Technology – US Regulatory Oversight

An Introduction to U.S. Department of Agriculture Labeling, Inspection and Ingredient Approval Requirements

Food Safety: Current Good Manufacturing Practices and Related Requirements; Unintended Components/Contaminants of Food

Food Safety: An Introduction to Ingredient Preclearance/Intentional Components of Food

The Regulation of Cosmetics: An Introduction

Overview of U.S. Food Law and Regulation: An Introduction

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

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

USPTO-FDA Collaboration: Progress Towards Patently True Interagency Coordination

FDA Inspections and Enforcement: Tobacco and Nicotine Product Manufacturers and Retailers

Tobacco and Nicotine Product Compliance

The Public Heath Standard for Tobacco and Nicotine Products

Pathways to Market for Tobacco and Nicotine Products

United States Tobacco and Nicotine Product Regulation: The Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Regulation

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

Enhancing Engagement Opportunities and Communication with FDA

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

Case Studies/Hypotheticals for an Introduction to Medical Product Advertising and Promotion

An Introduction to Other Agencies and Considerations Involved in Medical Product Advertising and Promotion

An Introduction to Dissemination of Information about Unapproved Uses for Medical Product Advertising and Promotion

An Introduction to Applicable FDA Offices, Essential Principles, & Key Definitions for Medical Product Advertising and Promotion

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

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 Tobacco and Nicotine Product Research

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

Introduction to Vaccine Regulation

Vaccine Development and Clinical Trials

Vaccine Pathways to Market

Vaccine Manufacturing, Scaling, Supply Chain, and Administration Issues

Vaccine Enforcement and Litigation

Examining the State of Drug Importation and Drug Pricing

An Introduction to Managing Promotional Issues for Medical Products in a Virtual Setting

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?

Intro to COVID-19: Drug Issues

Intro to COVID-19: Diagnostics and Laboratory Testing

Intro to COVID-19: Combating Fraudulent Products

Intro to COVID-19: Enforcement Action Guidelines, Legal Liabilities and Concerns

Intro to COVID-19: Personal Protection Equipment (PPE)

Intro to COVID-19: Ventilators and 3D Printed Devices

Intro to COVID-19: Public Readiness and Emergency Preparedness Act (PREP ACT)

Intro to COVID-19: Defining Emergency Use Authorization (EUA) Authorities

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)?

FDA-Related Congressional Committees: Jurisdiction, Focus, and Roles

Nicotine: What it Is, What it Does, and How to Effectively Communicate this Information to the Public

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

A Practical Guide to Bringing a Dietary Supplement to Market

Reducing Anti-Kickback Risks Associated with Medical Products

Introduction to the Regulation of Cannabis-Derived 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

Real World Evidence: Data Requirements, Utilization, and Presentation

FDA, USDA, and EPA: Inter-Agency Overlap and Jurisdictional Boundaries

PDUFA and BsUFA Reauthorization: Key Changes Affecting Industry and Patients

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

admin2024-03-20T12:50:45-04:00