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Update Magazineadmin2024-08-13T11:37:46-04:00

Summer 2024 Full Issue

Fall 2024

Battling Healthcare Misinformation Through Personal Agency

Summer 2024

FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes

2023 Year in Review—Canada’s Top 10 Drug and Medical Device Regulatory/Legal Issues

Some Appeal-Endangering Nuances of the Federal “Separate Document” Rule

Advancing 21st Century Regulatory Science via AI and HI

Legal and Ethical Considerations for Offering Clinical Trial Recruitment Payments and Enrollment Incentives

Spring 2024

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“Modernized” Food Manufacturing Enforcement: Trends in FDA Warning Letters

FDA Law and the Psychedelic Renaissance

Letter to the Editor: FDA Citizen Petition Seeks Historical Reckoning to Require the Labeling of Gluten on All Food Packages in the United States

Chevron Deference on the Brink: Small Fish May Mean Big Changes For FDA

Leqembi and the Accelerated Approval Pathway

The Curious Case of Aspartame: How the Same Evidence Can Yield Seemingly Different Conclusions

Winter 2023

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Tech Support: FDA’s Evolving Regulatory Plan for Drug- and Device-Enabling Software

Risk Sharing Agreements in Brazil

Implementing MoCRA: FDA Releases New Draft Guidances on Insanitary Conditions for Tattoo Ink and Cosmetic Product Registration & Listing

Food Labeling Regulation An Overview from Brazil and Latin America

The Accelerated Approval Program: Desiderata for a Proper Solution to the Untimely Completion of Confirmatory Trials

Regulatory Innovation: Where You Stand Depends on Where You Sit

Fall 2023

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The Grocer Will Fill Your Order Now: Modernizing Online Food Shopping Becomes a Priority for Federal Agencies

FDA’s Adoption of NSF/ANSI 455-3 National GMP Cosmetic Standard Under MoCRA Could Model World Class Example of Public–Private Partnership in a Once-a-Century Opportunity

Lacks v. Thermo Fisher Scientific Inc.—An Extraordinary Event from More than 70 Years Ago That Led to a Lawsuit, Resulting in a Settlement

Ferrari v. Vitamin Shoppe: A Favorable Ruling for a Manufacturer Facing a Challenge to Its Dietary Supplement Structure/Function Claims

FDA Review of New Tobacco Products: A Public Health Narrative

Suggestions for Improvement of FDA Review of New Tobacco Products

Reality-Based Healthcare Reform

Summer 2023

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Advancing the Transition to Computer Software Assurance: Responding to the FDA Draft Guidance for Production and Quality System Software

Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA’s Marketing Denial Order

Food and Beverage Container Labeling and Allergen Management: Protecting Consumer Health

Alternative Proteins: Navigating the Maze of U.S. Federal and State Meat Labeling Requirements

2022 Year in Review—Top 10 Food and Agribusiness Regulatory and Legal Issues in Canada

Important Recent Updates to DOJ Policy on Voluntary Self-Disclosure and Corporate Compliance Programs

Regulating Contrast Agents as Drugs: What’s Next for FDA?

Product Testing, Questionable Science, and the Smallest, Big Developments in Consumer Product Litigation

Spring 2023

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FTC and NAD Remind Industry of Their Authority Over All Health Product Advertising (Including Rx)

FDA Amends Final Ruling for Yogurt Standard of Identity

MoCRA Is Here—Now What? Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA’s Enactment

An Overview of Food and Drug Law Practices, 2023 Update

Association of Clinical Research Professionals’ Response to FDA Draft Guidance on Diversity in Clinical Trials: Increased Diversity Should Be a Requirement, Not a Suggestion

Establishing an FDA office in the Middle East/North Africa: An Abraham Accords Initiative

Winter 2022

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Direct-to-Patient Sample Distribution in the Time of COVID-19

Federal Funding of Medical Countermeasures: Opportunities, Risks, and Enforcement Trends

FDA Hosts Virtual Listening Session on Improving Regulation of Animal Foods with Certain Types of Claims

Adoption Patterns of the FDA Food Code Across U.S. States

Letter to the Editor

Fall 2022

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What’s in a Name? Updates on Plant-Based Product Labeling Regulations

Senate Bill and FTC 6(b) Study Turn the Heat on Pharmacy Benefit Managers Amid Drug Pricing Concerns

Gene-Edited Plants Get Lighter Regulatory Touch in New Health Canada Guidance for Foods

340B and the Warped Rhetoric of Healthcare Compassion

Deploying Agile as an Innovative Risk Management Framework in Pharma

State-by-State Patchwork Creates Onerous Burdens for 503B Outsourcing Facilities

The Status of California’s Pay-for-Delay Legislation & Litigation

Summer 2022

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Legal Updates on PFAS in Products

Senator Spooner Got It Right: Uniform National Regulatory Norms for Cannabis

USDA Issues Transitional Nutrition Standards for School Meals

Spring 2022

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FDA Guidance in Response to COVID-19 and a Plan for Transition Back to Normal

Drug CGMP During COVID-19: An Analysis of Recent FDA Warning Letters

Reverse Distribution: Serving Public Health Under Range of State Rules

A Part D Pay-It-Forward Proposal

Winter 2021

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FDA Focuses on Safety With the New Cannabis-Derived Product Data Acceleration Plan (DAP)

Technical Project Lead (TPL) Reviews by the FDA Center for Tobacco Products Are Key to Improving Science and Public Health Communication

The Future of Food? CRISPR-Edited Agriculture

Strengthening the Regulation of Dietary Supplements—Lessons from Prevagen®

Fall 2021

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FDA Emergency Use Authorization: A Brief History From 9/11 to COVID-19

Can Food Labeling Policy Advance Health Equity?

Fido Has it All Figured Out: Lessons Learned from Animal Supplements May be Useful to Those Seeking a Human CBD Supplement Pathway

Biosimilar Strength vs. Potency: Avoiding a Regulatory Hobson’s Choice

Will FDA Extend Its Proposed Ban on Menthol Cigarettes and Characterizing Flavors in Cigars to Flavored ENDS Products?

Summer 2021

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FDA Drug Manufacturing Oversight During Covid-19: The GAO Report on the Inspections Backlog and Steps FDA is Taking to Address It

Orphan Drugs in Canada: A “One Size Fits All” Regulatory Regime

Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations

Pharmaceutical GMPs, Quality Control, and Data: A Deeper Look at FDA’s FY 2020 FDA Observations

Letter to the Editor: Recent FDA Activity on Cannabis Clinical Research

Juul Labs: Advancing the Scientific Dialogue About Tobacco Harm Reduction

New Bioengineered (aka GM) Food Disclosure Law: Useful Information or Consumer Confusion?

Spring 2021

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Going Up the Chain: Escalation of Significant Issues in Life Sciences Companies

Sourcing Cannabis Lawfully for CBD Consumer Products: Challenges and Opportunities

The Approaching Bioengineered Food Disclosure Deadline: Enforcement and Litigation Landscape After January 1, 2022

2020 Year in Review—Canada’s Top 10 Drug and Vaccine Regulatory Updates

Will 2021 Be a Pivotal Year for the CBD Industry? A Look at the Regulatory Landscape and Potential for Change

The Tobacco Industry and the Scientific Community: A Public Health Response

The WTO’s Decision on Australia’s Plain Packaging Tobacco Measures Explained

Winter 2020

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The Question of Mitigating Patient Mortality: Comparing Gilead’s ACTT-1 and the WHO’s Solidarity Trials

A Look Back at Risk Evaluation and Mitigation Strategies at the Food and Drug Administration in 2020: Year in Review

Regulations of CAR T-Cell Therapies—The Past, Present, and Future

Antitrust Treatment of Acceleration Provisions in Hatch-Waxman Settlements

Focusing on the Patient: Implementation of Key 21st Century Cures Provisions and Recommendations for the Future

Real World Evidence: A Potential Solution

Improving Cooperation Between the Nicotine Industry and the Scientific Community: The Swedish Match Science Advisory Panel Experience

Deconstructing the Consent Decree: A Primer and Recent Trends for FDCA Injunctions

That Will Leave a Mark: FDA’s Shifting Approach to Regulating the Coronavirus Testing Market Creates Confusion, Opportunities, and Enforcement Risk

Fall 2020

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Businesses Beware: FTC Seeks to Codify “Made in USA” Enforcement Policy

Bad News for Device Sponsors: Panel Meetings were Already Going the Way of the Homework Assignment, and COVID Might “Put the Nail in the Coffin”

Keeping Track of the Quacks: Drug and Device Enforcement in the COVID-19 Era

Lessons from Recent Medical Device Criminal Resolutions

How Will FDA Regulate Disease-Sniffing Dogs?

Summer 2020

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COVID-19 Response Focuses Renewed Interest in FDA’s Stance on Donations of FDA-Regulated Products

The Impact of DOJ’s Evaluation of Corporate Compliance Programs on FDA-Regulated Products

OTC Monograph Reform Legislation is Now Law—What Does It Do?

More Foreign Drug Companies Registering Drug Master Files in China

FDLJ Symposium Spotlight: Development and Regulation of Innovations: In the Current State of Facts vs. Public Opinions, the Truth Does Not Always Prevail

Spring 2020

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A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD

Chevron’s Hard-Hitting Footnote Nine Revived by Kisor v. Wilkie and Recent Decisions on Deference

Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents

Taking Stock of PFDD: Envisioning a Vibrant Future for Patient-Focused Drug Development

You Can Smoke Tobacco, Sugar Cane, or Newspapers, But You Cannot Vape

Update EXTRA

Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community.

FDA Holds Public Meeting on PMTAs for Deemed Products Meeting Summary

New Dietary Ingredients (NDI) and Innovation in Dietary Supplements: A Call for New Compliance and Enforcement Strategies

How Will FDA Bring Order to the Wild West of Cannabis Regulations?

FDA Holds Scientific Workshop on Youth E-Cigarette Cessation Treatment Strategies

November/December 2019

Ready or Not, Here It Comes! The Drug Supply Chain Security Act Requirements Are Almost Fully Upon Us. Are You Prepared?

CBD Enforcement– Who is Keeping Watch?

The Challenges of Communicating Regulatory Status to the Public

Brazil: New Regulation of Cannabis-Based Drugs Coming Soon

July/August 2019

BYOD and eCOA: A Match Made in Heaven?

New Developments in DTC Television Advertising: Disclosing Prescription Drug List Prices

Food and Drug Law Journal Symposium Spotlight: Cannabis Clinical Investigations in Colorado 2019

Continuous Manufacturing in Pharma: FDA Perspective

April/May 2019

PMA Advisory Panels: Do their Votes Matter?

Device Cybersecurity: How FDA and Others are Collaborating to Increase Patient Safety

Canada 2018 Year in Review: Top 10 Medical Device Regulatory Issues

Over-the-Counter Drug Monograph Reform Legislation in the 116th Congress

Communicating with FDA When Data Integrity Issues Arise During Clinical Trials

Global Regulatory Focus | China: Survival of the Fittest or Cheapest

Spotlight on Tobacco: Reduced-Risk Tobacco Products: A Case of Policy Vacuum in India

February/March 2019

Food Additive Reform: Time to Repeal the Delaney Clause?

Soy Milk, Spilt Milk? FDA’s Next Free Speech Conundrum

The Legalization of Hemp

Canada 2018 Year in Review: Top 10 Food Regulatory and Legal Issues

Status Quo Maintained: FDA Reverses Course on Generic Product Labeling

Global Focus: Japan’s Regenerative Medicine Regulatory Pathways

December 2018/January 2019

The Responsible Corporate Officer Doctrine: Protections are Needed Despite DOJ’s Cautious Approach

JUUL in Schools: Can FDA Close the Youth On-Ramp While Still Maintaining the Off-Ramp for Adult Smokers?

The Criminalization of Dietary Supplement Enforcement

Un-“Stacking” Class Actions

A Storm Is Brewing: What Happened to the Generic Pharmaceutical Anti-Trust Price Fixing Criminal Investigation?

Gene Therapy – FDA Takes Steps Toward Clarifying Scope of Orphan Drug Exclusivity

FDA’s New Pilot Program Encouraging Innovation

October/November 2018

Spotlight on Tobacco | Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway

Medical Device Crowdfunding and Pre-Approval Promotion: Where Does FDA Draw the Line?

Epidiolex Approval Suggests the Way Forward for Marijuana-Derived Products

Digital Health – FDA’s Approach Will Continue to Evolve

Case Study: Jazz Pharmaceuticals v. Amneal Pharmaceuticals

Student Corner: Right to Try Act: Is it the Answer for Terminally Ill Patients?

Global Focus: Clinical Trials in India

Organs on a Chip! FDA’s Predictive Toxicology Roadmap

August/September 2018

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

FDA’s Historical Use of “Real World Evidence”

For FDA, Addressing Drug Pricing Is a Matter of Doing Its Job Better

The DEA Quota System

Public Law 115-92: A New Era of Collaboration between DoD and FDA

Canada’s Green Rush – Getting Ready for The Legalization of Adult-Use Cannabis

Cracking Down on Kratom: FDA Investigation, Enforcement, Seizure, and Recall of Products Reported to Contain Kratom

Connecting the Dots: Reaffirming the Importance of the Produce Safety Rule & Tracing Technology with the Romaine Lettuce Outbreak

June/July 2018

FDA in the New Administration: Policy and Enforcement Priorities for the Coming Year

FDA Leadership: Policy Developments, Enforcement, and Priority Initiatives for 2018

Commemorating the 80th anniversary of the Passage of the 1938 Food, Drug, and Cosmetic Act

Case Note: Cigar Association of America v. FDA

Reasonableness and Food Advertising: A View from Mexico

Consultants as Part of the Legal Team

Careers in Food and Drug Law

March/April 2018

What’s New at FDA for Medical Products and Foods?

FDA’s Tools to Respond to Public Health Emergencies

You’re in Better Hands Than You Think: Insurance Law May Provide Coverage for Defense of Advertising Claims

FDA Data Integrity Enforcement Trends and Practical Mitigation Measures

FDA Plan for Tobacco and Nicotine Regulation

Protecting Trade Secrets in the Medical Product Approval Process

China: Breaking Down the “Great Wall”?

Top 10 Updates on Canadian Market Access, Exclusivity, and Pricing Issues

January/February 2018

The Food Safety Modernization Act, After One Year: Advancing and Building Food Safety Systems for the 21st Century

What’s in a Name? Sometimes, a Claim

Laws and Regulations Concerning Cell-Cultured Meat and Cellular Agriculture

Navigating an FTC Drug Pricing Investigation

Eye on Enforcement

November/December 2017

Food Litigation Trends: New and Undefined Label Claims in 2017

DEA Preregistration and Cyclic Inspections: What Applicants and Registrants Must Know in the Prescription Opioid Epidemic Age

Inaugural Wiet Life Science Law Scholars Conference

Capturing Postmarket Benefits in Device Compliance and Enforcement

Those Involved in Compound Pharmaceuticals Beware: Law Enforcement Is Focused on You

What Happens When FDA Delays a Rule? Menu Labeling as a Case Study

The Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls

The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI

September/October 2017

Compounding the Off-Label Promotion Debate: How FDA Could Regulate the Promotion of Unapproved Drugs

Intellectual Property for the Food and Drug Law Professional: Issues that Arise in the Product Development Process

The “New” NDC: Are You Aware of FDA’s Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?

FDA’s Comprehensive Approach to Nicotine and Tobacco

Regulatory Update on Acrylamide—State, Federal, and International Oversight

The Changing Face of Marijuana Regulation: Current Federal Status

India: Pharmaceutical Legal & Regulatory Environment

Japan: A Better Environment

July/August 2017

Prescription Drug Advertising and Promotion Regulations and Enforcement in Select Global Markets

“Consistent Communications”: FDA’s Incremental Expansion of Promotional Bounds

Sales Reps in the OR: Best Practices for Medical Device Manufacturers

Process Labeling: The Challenges of Transparency

California Trial Court Cuts Plaintiffs’ Bait in Tuna Misbranding Suit

Case Note: Sandoz v. Amgen

FDA Sharpens its Focus on Regenerative Medicine Regulation

Spotlight on Tobacco: A Model Risk Continuum for Tobacco and Nicotine Products

The Butterfly Effect: Reuse of a Needle Guide Triggers “Fundamental Threat to Federal-State Balance”

May/June 2017

Drugs and Biologics: New Administration, New Legislation, New Precedents

Momentum Builds for Medical Device Cybersecurity to Level Up

Food and Dietary Supplement Class Actions

Tobacco Deeming: One Year Later

FDA Inspections: The Changing Landscape

21st Century Cures Act Implementation

FDLI Annual: By the Numbers

March/April 2017

LDTs: The Saga Continues

Factors to Consider Before Submitting a De Novo Request

Intellectual Property for the Food and Drug Law Professional: The Product Development Process

21st Century Cures Act Provides (Some) Clarity on FDA’s Regulation of Software

Interview: James Valentine Talks to Christine McSherry, Jett Foundation

January/February 2017

Letter from the Chair

Voluntary and Mandatory Claims About Foods and Genetic Engineering

FDA’s 2016 New Dietary Ingredient Draft Guidance

Top 10 Food and Tobacco Product Issues in Canada

India: Paradigm Shift in Food Regulatory Environment

FDLI Welcomes New Board Members and Executive Committee

November/December 2016

FDCA Conviction without Evidence of Knowledge or Intent?

A Brave New Food Enforcement World

New Antitrust Risks from Introducing New Drugs

CRN on the CRN-NAD Advertising Review Program

The NAD: A Force in Shaping Food and Dietary Supplement Advertising

Fighting with KINDness: FDA’s Unhealthy Enforcement of the “Healthy” Nutrient Content Claim Regulation

Interview Amy Rick Talks to Stephen Ubl, PhRMA

EU Agrees on New Medical Device and IVD Regulation

GLOBAL FOCUS: The Approval and Substitutability of Biosimilars: Potential Impact on Use and Competition