Webinars

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

Recorded February 23, 2023 | On-Demand Webinar

Advocacy Without Antagonism: Principled Counseling in Food and Dietary Supplement Class Actions

Recorded February 9, 2023 | On-Demand Webinar

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

Recorded January 25, 2023 | On-Demand Webinar

The Future of Food Regulation: Assessing the Reagan-Udall Foundation’s Report on FDA’s Human Foods Program

Recorded January 24, 2023 | On-Demand Webinar

Fundamentals of FDA Regulation of Cosmetics

Recorded December 13, 2022 | On-Demand Webinar

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

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

Understand the generic drug approval pathway and requirements of sameness, bioequivalence, and therapeutic equivalence. Recognize patent listing and certification requirements and […]

Supply Chain Mayhem: Industry Impacts and What Can be Done

Recorded October 6, 2022 | On-Demand Webinar

Food and Dietary Supplement Imports and International Issues: An Introduction

Receive an overview of FDA’s food import authority. Become familiar with FDA’s international presence and activities that safeguard the public health.

Riëtte van Laack , […]

FDA Inspection and Enforcement Authority for Food and Dietary Supplement Manufacturers

Review FDA’s inspections and enforcement authorities. Differentiate FDA’s various enforcement tools.

Brigid Bondoc , Of Counsel, Morrison and Foerster, LLP

This session was recorded […]

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

Become familiar with the Federal Trade Commission’s role and statutory authority regarding food advertising. Distinguish and understand who regulates […]

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

Identify what is a claim, and who regulates claims on foods. Discuss the various types of claims. Understand the federal statutory authorities, […]

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

Understand food labeling requirements and the concept of misbranding. Prepare to differentiate “label” from “labeling” under the Federal Food, Drug and Cosmetic […]

The Regulation of Dietary Supplements: An Introduction

Learn what is a dietary supplement and examine statements of nutritional support and structure function claims. Summarize dietary supplement safety, Serious Adverse Event Reporting (SAER) requirements, […]

Foods Derived from Biotechnology – the USDA/FDA Conundrum

Learn about the various agency roles under the Coordinated Framework for Regulation of Biotechnology.
Analyze the interplay between FDA’s voluntary plant biotechnology consultation program and the […]

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

Learn which foods are regulated by United States Department of Agriculture (USDA). Identify the similarities and differences between FDA and […]

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

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

Learn the definition and applications of “adulteration”. Discuss current Good Manufacturing Practices (cGMPs) and its relation to food. Examine the […]

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

Summarize the definitions of “food additive,” the food additive approval requirements, and recognize the application of Generally Recognized as Safe (GRAS) substances.

Xin Tao, […]

The Regulation of Cosmetics: An Introduction

Understand how cosmetics are regulated. Define “cosmetic” and “color additives”. Differentiate cosmetics vs. drugs and/or devices. Summarize cosmetic labeling and warning requirements.

Steven Armstrong , Senior Regulatory Advisor, […]

FDA and Alcohol: Trends in Alcoholic and Alcohol-Free Products, Regulatory Framework, and Marketing and Labeling Compliance

Recorded on April 12, 2022 | On-Demand Webinar

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

Recorded October 7, 2021 | On-Demand Webinar

Modified Risk Tobacco Products (MRTPs): Navigating the MRTP Process, Post-Order Marketing, and Assessing Whether it is an Effective Tool for Risk Communication

Recorded July 30, 2020 | On-Demand Webinar

COVID-19 and Tobacco and Nicotine Products: Enforcement Disruptions, Industry Impact, and Possible Links Between Product Usage and Contracting or Worsening the Illness

Recorded June 18, 2020 | On-Demand Webinar

What Does Current Cannabis Research Tell Us and What Are Future Prospects for Research Access?

Recorded June 3, 2020 | On-Demand Webinar

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

Recorded June 2, 2020 | On-Demand Webinar

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

May 19, 2020 | On-Demand Webinar

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

Recorded May 14, 2020 | On-Demand Webinar

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

Recorded April 14, 2020 | On-Demand Webinar
Complimentary Webinar

COVID-19 and Beyond: Crisis Preparation, Management, and Recovery in the Food and Dietary Supplement Industries

Recorded March 23, 2020 | On-Demand Webinar

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

Recorded March 19, 2020 | On-Demand Webinar

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

Recorded March 4, 2020 | On-Demand Webinar

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

Recorded February 18, 2020 | On-Demand Webinar

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

Recorded January 22, 2020 | On-Demand Webinar

The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps

Recorded January 21, 2020 | On-Demand Webinar

A Practical Guide to Bringing a Dietary Supplement to Market

Recorded December 19, 2019 | On-Demand Webinar

Reducing Anti-Kickback Risks Associated with Medical Products

Recorded October 3, 2019 | On-Demand Webinar

Class Action of FDA-Regulated Products: Recent Updates and Future Forecasts

Recorded August 21, 2019 | On-Demand Webinar

Introduction to the Regulation of Cannabis-Derived Products

Recorded August 1, 2019 | On-Demand Webinar

Introduction to Product Liability Regarding FDA-Regulated Products

Recorded July 23, 2019 | On-Demand Webinar

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

Recorded July 18, 2019 | On-Demand Webinar

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

Recorded May 14, 2019 | On-Demand Webinar

New Management Standards for Hazardous Waste Pharmaceuticals and Nicotine

Recorded March 6, 2019 | On-Demand Webinar

Prop 65: Emerging Issues in California’s Law

Recorded February 27, 2019 | On-Demand Webinar

Patient Assistance Programs: Recent Enforcement and Best Practices

Recorded February 7, 2019 | On-Demand Webinar

FDA in Partial Shutdown – What Do We Know About Who’s Doing What?

Recorded January 24, 2019 | On-Demand Webinar

Opioid Legislation: The Path Forward for FDA and DEA Webinar

Recorded December 18, 2018 | On-Demand Webinar

From Approval to Coverage – FDA and CMS Jurisdictional Lines

Recorded September 27, 2018 | On-Demand Webinar

Guidance on Guidance: FDA, DOJ, and Enforcement

Recorded August 21, 2018 | On-Demand Webinar

Drug Pricing for the Food and Drug Community

Recorded July 17, 2018 | On-Demand Webinar

Cell-Based Meat and Other Modified Foods

Regulatory Concerns and Potential Pathways Forward
Recorded June 26, 2018 | On-Demand Webinar

Organic Chemistry for the Food and Drug Community

Recorded June 21, 2018 | On-Demand Webinar

USDA’s Proposed Bioengineered Food Disclosure Standard

Key Issues and Next Steps
Recorded June 14, 2018 | On-Demand Webinar

DEA Law for the Food and Drug Community

Recorded May 30, 2018 | On-Demand Webinar

Data Integrity: FDA Enforcement and Risk-Reduction Considerations

Recorded March 13, 2018 | On-Demand Webinar

First Amendment Issues in Advertising and Product Packaging Webinar

Recorded February 13, 2018 | On-Demand Webinar

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

Recorded February 9, 2018 | On-Demand Webinar

Real World Evidence: Data Requirements, Utilization, and Presentation

Recorded December 1, 2017 | On-Demand Webinar

Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for Industry

Recorded November 29, 2017 | On-Demand Webinar

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

Recorded November 17, 2017 | On-Demand Webinar

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

Recorded November 9, 2017 | On-Demand Webinar

PDUFA and BsUFA Reauthorization: Key Changes Affecting Industry and Patients

Recorded September 12, 2017 | On-Demand Webinar

Regulation of Cannabis in FDA-Regulated Products

Recorded July 19, 2017 | On-Demand Webinar

The EU’s New Medical Device and IVD Regulations

Recorded June 7, 2017 | On-Demand Webinar

REMS: Key Issues and Best Practices

Recorded May 23, 2017 | On-Demand Webinar

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

Recorded May 18, 2017 | On-Demand Webinar

False Claims Act Enforcement

Recorded April 4, 2017 | On-Demand Webinar

Recent FDA Guidance Documents on Manufacturer Communications about Medical Products

Recorded March 16, 2017 | On-Demand Webinar

21st Century Cures Act

Recorded December 21, 2016 | On-Demand Webinar

The Yates Memo: A Lawyer’s Professional Responsibility

Recorded December 14, 2016 | On-Demand Webinar

Social Media: Innovative Uses and Practical Experiences

Recorded November 17, 2016 | On-Demand Webinar

Mandatory GMO Labeling: Preparing for Implementation

Recorded August 31, 2016 | On-Demand Webinar

New FDA Nutrition Facts Label: Implications for Industry

Recorded June 29, 2016 | On-Demand Webinar

A First Look at the Deeming Regulations: A Two-Part Webinar

Recorded June 15, 2016 | On-Demand Webinar

New Changes to California’s Prop 65: What Do They Mean for You?

Recorded April 21, 2016 | On-Demand Webinar

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

Recorded March 14, 2016 | On-Demand Webinar

Marijuana Regulation in the Food and Drug Realm

Recorded February 12, 2016 | On-Demand Webinar

Upcoming

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