Archives
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Association of Clinical Research Professionals’ Response to FDA Draft Guidance on Diversity in Clinical Trials: Increased Diversity Should Be a Requirement, Not a Suggestion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
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
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
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
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
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®
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?
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
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?
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
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
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?
FDLJ Symposium Spotlight: Development and Regulation of Innovations: In the Current State of Facts vs. Public Opinions, the Truth Does Not Always Prevail
COVID-19 Response Focuses Renewed Interest in FDA’s Stance on Donations of FDA-Regulated Products
OTC Monograph Reform Legislation is Now Law—What Does It Do?
The Impact of DOJ’s Evaluation of Corporate Compliance Programs on FDA-Regulated Products
More Foreign Drug Companies Registering Drug Master Files in China
A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD
<i>Chevron</i>’s Hard-Hitting Footnote Nine Revived by <i> Kisor v. Wilkie </i> 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
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
FDA Holds Public Meeting on PMTAs for Deemed Products Meeting Summary
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
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
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
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
FDA Holds Public Hearing on Strategies to Address Youth E-Cigarette Use
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
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
Facilitating Competition and Innovation Isn’t Easy: FDA’s Latest Hearing On Biologics
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
FDA Tackles Cell-Cultured Foods
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
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
Top 10 Updates on Canadian Market Access, Exclusivity, and Pricing Issues
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
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
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
How Can FDA Address the Opioid Addiction Crisis?
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”
FDA Looks at Improving Implementation of the Hatch-Waxman Amendments
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
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
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
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
Continuing the Discourse: FDA’s Public Hearing on Off-Label Communications
