
Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, biologics, regenerative medicine products, foods, cosmetics, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications.
Her strategic counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, including:
- Determining regulatory status of novel products;
- Pre-market and post-market requirements for various regulated products;
- Restrictions on advertising and product sampling;
- State licensing schemes for prescription drug manufacturers and distributors;
- Federal track-and-trace obligations for all members of the prescription drug supply chain, from manufacturers to pharmacies;
- Compliance with prescription drug compounding regulations;
- Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
- Advising on or preparing clients’ written submissions to FDA requests for comments or rulemaking activities;
- Requirements for importing and exporting regulated products; and
- Food safety and labeling advice for food, including dietary supplements and functional foods.
Joanne frequently works with clients to develop and implement their responses to common FDA actions, such as warning letters and inspectional reports (the “Form 483”). She has also been involved in advising and helping clients respond to Federal Trade Commission investigations related to product advertising and requests for substantiation of certain promotional claims.
As an FDA regulatory specialists, Joanne assists the Mintz corporate team by performing regulatory due diligence as part of potential mergers and acquisitions that involve regulated companies, and she often works in conjunction with the Firm’s intellectual property attorneys to ensure that patent and regulatory activities are strategically aligned. She also collaborates regularly with Mintz attorneys who negotiate royalty monetization transactions. Although the day-to-day work for clients may be different, the common thread that she enjoys most is helping companies (both start-up and established) bring their products to market – without heightened risks of enforcement actions as a result of non-compliance with sometimes-opaque regulatory requirements.
Prior to joining Mintz, Joanne was an attorney in the food and drug practice in the DC office of another law firm.
Joanne is an editor of and frequent contributor to the firm's Health Care Viewpoints.
Experience
- Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face shields, face masks, and alcohol-based hand sanitizers in compliance with FDA’s enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
- Guided clients developing COVID-19 diagnostic or serological tests on various promotional risks and regulatory obligations both before and after they secure Emergency Use Authorizations from FDA that allow the test to be distributed and used in the United States.
- Prepared a Breakthrough Designation Request on behalf of a therapeutic developer client and helped another client secure Orphan Drug Designation for its innovative drug product.
- Participates in the Medical, Legal, and Regulatory (“MLR”) Committees that are engaged in promotional review activities on behalf of multiple clients with recently approved new drugs and biologics. Also assists various companies that market non-prescription consumer products in structuring and implementing their Advertising Compliance Programs and ensuring ongoing risk mitigation in new promotional activities or when launching new products.
viewpoints
Mintz Health Law: What We Are Grateful For
January 11, 2023 | Podcast | By Bridgette Keller
FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic Modernization, and Expansion of Certain Existing Programs
January 10, 2023 | Blog | By Joanne Hawana
Cosmetic Regulatory Reform Finally Becomes Law
January 3, 2023 | Blog | By Joanne Hawana , Jean D. Mancheno

Regulatory Roundup: Important FDA Developments at the End of September 2022
October 10, 2022 |Blog
FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence
September 28, 2022 | Blog | By Benjamin Zegarelli, Joanne Hawana
Pharmaceutical Manufacturer Pays $7.9 Million to Resolve Allegations that it Caused the Submission of Over-the-Counter Drugs to Medicare Part D
September 20, 2022 | Blog | By Joanne Hawana , Rachel Yount
FDA Announces Review of Opioid Prescribing Regulations and Framework for Preventing Overdose-Related Deaths
September 7, 2022 | Blog | By Joanne Hawana , Samantha Kingsbury
Will a Nonprescription Birth Control Pill Be FDA’s First Approval under its Long-Awaited “ANCU” Proposed Rule?
July 20, 2022 | Blog | By Joanne Hawana
News & Press
Mintz Forms Pioneering Women’s Health & Technology Practice
March 09, 2023
Mintz Debuts 'Femtech' Practice For Life Science Clients
March 9, 2023
MoCRA- Industry Must Prepare For Mandatory Adverse Event Reporting And Safety Substantiation Now: Expert
January 11, 2023
Pared-Down FDA-Fee Bill Moving With CR
September 28, 2022
Charting A Year Of The Biggest COVID Scams Cited By FDA
March 15, 2021
Mintz Advises NexImmune in its Upsized $126.5 Million IPO
February 17, 2021
Legal Risks of Employer-Sponsored Covid-19 Workplace Vaccination Clinics
February 12, 2021
User Fees Will Be A Focus For Senate HELP, No Matter Who’s In Charge
November 5, 2020
COVID-19: Regulators Confronted with Scourge of ‘Fake Cures’
September 29, 2020
Introduction to the Due Diligence Process
July 27, 2020
Mintz Practice Groups and Attorneys Garner Top Rankings in 2020 Edition of The Legal 500 United States
June 12, 2020
What FDA Has Done So Far In Response To COVID-19
April 1, 2020
Mintz Promotes Eleven Attorneys to Member
May 10, 2019
FDA Finally Hitting Sweet Spot With Off-Label Oversight
November 21, 2018
MODERN Labeling Act Needs Liability Protection for Generics
November 14, 2018
Cosmetic Companies Must Plan For New Regulation
December 14, 2017
But What About Food? FDA Director Scott Gottlieb’s 4-month Scorecard
September 14, 2017
Mintz Attorney Says New FDA Organizational Changes Could Have Big Food Industry Effects
July 5, 2017
5 Ways Trump Could Change Food Safety Compliance
April 26, 2017
New FDA Enforcement Stats Show Shifting Targets
February 13, 2017
Will FDA Adverse Event Data Release Mean More Lawsuits?
January 18, 2017
The FDA targeted DTC, video, unapproved drug promotion in 2016
January 18, 2017
FDA Sticks to Its Naming Plan for Biologics and Biosimilars
January 13, 2017
Health Care Enforcement Review And 2017 Outlook: Part 1
January 13, 2017
Mintz Attorney Joanne S. Hawana to Speak at 2016 TEDCO Entrepreneur Expo
November 02, 2016
Why FSMA collaboration is the new normal in food transportation
November 1, 2016
Providers, Pharmacists Call for Earlier FDA Guidance on Biosimilars
October 24, 2016
Food Safety Regulations Will Affect California Tort Law
July 13, 2016
GE Salmon Sets Stage For Future GMO Labeling Regime
June 27, 2016
Food Companies Are Hedging Their Bets With GMO Labeling
April 25, 2016
Events & Speaking
Guide to Advertising for Life Sciences Companies: Insights from Legal and Business Perspectives
Association of Corporate Counsel San Francisco
Online Event

The Food and Drug Administration (FDA): Series Spanning Key Topics
Regulation of Foods & Cosmetics

US Regulation of Advertising, Promotion and Labeling for Medical Devices
Regulatory Affairs Professionals Society (RAPS)

DIA Advertising and Promotion Regulatory Affairs Conference
Drug Information Association (DIA)
Arlington, VA

Pro Bono in a Virtual Age: A conversation with KIND, Legal Aid Society, and Bread for the City
Kids In Need Of Defense (KIND)
Online Event

US Regulation of Advertising, Promotion and Labeling for Medical Devices
Regulatory Affairs Professional Society (RAPS)
Online Event

Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies
Food and Drug Law Institute
Online Event

Mandatory or Voluntary Workplace Vaccination – Guidance for Employers
This is an online event.

Food and Drug Law Institute Annual Conference
FDA’s Amended Intended Use Regulation – Has It Finally Hit the Sweet Spot?
Online Event

DIA Advertising and Promotion Regulatory Affairs Conference
Engaging with Patients to Diversify Advertising and Promotional Activities
Online Event

Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic
View the Webinar Recording

Introduction to Biologics and Biosimilars Law and Regulation Course Presented by FDLI
Regenerative Medicine Advanced Therapies (RMATs)
ELabs NYC
Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies
New York, NY
Six-Month Assessment: The Impact of Gottlieb’s Departure on FDA Priorities
Mintz, 3580 Carmel Mountain Road | Suite 300, San Diego, CA
RAPS Virtual Program: US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2-Part Series)
Navigating Federal Trade Commission (FTC) Requirements for Medical Products
Food and Drug Law Institute Annual Conference
Regenerative Medicine, Gene Therapies, and FDA Regulation
Washington, DC
FDLI's Introduction to Drug Law and Regulation Course
Regulation of Over-the-Counter OTC Drugs
Lake County, Illinois
ELabs NYC
Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies
New York, NY
Drug Compounding Post-DQSA: Emerging Regulatory Challenges & Business Opportunities
Mintz, One Financial Center, 38A, Boston, MA 02111

The 9th Annual Advertising and Promotion of Medical Devices Conference
FTC’s Authority Applied to the Regulation of Medical Devices
The Madison Hotel, Washington, D.C.
Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance
FDANEWS
Webinar
Recognition & Awards
- William P. Cunningham Award for Achievement and Service to the School of Law, University of Maryland (2007)
- Manuscripts Editor, The Journal of Health Care Law and Policy (Vol. 10)
- Recognized by The Legal 500 United States for Healthcare: Service Providers (2020)
- Recognized by The Legal 500 United States for Healthcare: Life Sciences (2021)
- JD Supra: Top Author, Readers' Choice Awards – Life Sciences (2021)
- Pro Bono Advocate of the Year Award, Kids In Need of Defense (KIND) (2023)
Involvement
- Member, Food and Drug Law Institute (FDLI)
- Member, FDLI Publications and Academic Programs Committee
- Member, Drug Information Association (DIA)
- Member, American Bar Association (ABA), and ABA Health Law Section
- Member, American Health Lawyers Association (AHLA), and AHLA Life Sciences Practice Group
- Past Chair, FDLI Publications Committee
- Past Chair, FDLI Primer Committee
- Past Chair, FDLI Update Magazine Editorial Advisory Board
