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, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to precision medicine and the impact of the agency’s policies on product development and marketing plans.
Her strategic counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, including:
- Determining regulatory status of novel products like mobile health systems and point-of-care diagnostics;
- Pre-market and post-market requirements for various regulated products;
- Restrictions on advertising and sampling, including for controlled substances;
- 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 drug compounding regulations, both State and Federal;
- Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
- Advising on clients’ written submissions to FDA requests for comments or rulemaking activities, and in some cases preparing those submissions on behalf of private companies or patient advocacy groups;
- Requirements for importing and exporting regulated products; and
- Food safety and labeling advice for human and animal food, including dietary supplements and so-called 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.
Joanne also 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 has developed a distinctive relationship with Mintz attorneys who negotiate royalty monetization transactions and works closely with them in developing the terms for these unique 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.
Education
- University of Maryland School of Law (JD, cum laude)
- University of Medicine and Dentistry of New Jersey, Graduate School of Biomedical Sciences (MS, Molecular Genetics & Microbiology)
- College of William & Mary (BS, Biology)
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.
- Assisted multiple pharmacy clients in determining whether to register with FDA as an Outsourcing Facility and advised them regarding the compliance obligations associated with this form of compounding business, including with respect to applicable COVID-19 enforcement discretion policies.
- Negotiated with FDA on behalf of a cosmetic client when a large shipment of imported products was detained by Customs and Border Protection due to non-compliant labeling and assisted company in developing plans for reconditioning the products.
- Counseled a cosmetic company on its response to an FDA Warning Letter related to the use of drug claims to promote cosmetic products and then assisted in the company’s implementation of internal processes and procedures to avoid similar issues in the future.
- Represented an innovative beverage company with a national profile on FDA compliance issues, labeling, promotional activities, and distribution agreements.
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)
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
Recent Insights
Viewpoints
Health Law Diagnosed — Mintz’s 2022 Health Law New Year’s Resolutions
January 12, 2022 |Podcast
News & Press
Events
Joanne Hawana is the chairperson and moderator of the session titled, "Drug/Device Company Interactions with Patient Advocacy Groups: Working Collaboratively and Compliantly," at the DIA Advertising and Promotion Regulatory Affairs Conference.
Join Joanne Hawana and Benjamin Zegarelli for a fireside chat of policy activities that will likely have the greatest impact on stakeholders in 2022. Their discussion will also consider how the new FDA Commissioner and various proposals working their way through Congress may impact the FDA going forward.
Joanne Hawana will be participating in a Kids In Need Of Defense (KIND) lunchtime discussion on the logistics of committing to doing pro bono work in a virtual age on October 25.
Viewpoints
Co-Owner of Clinical Trial Company Pleads Guilty to Obstruction of Justice in Connection with Falsification of Clinical Trial Data
January 18, 2022 | Blog | By Jane Haviland, Joanne Hawana, Kate Stewart
On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection. Olga Torres co-owned the clinical research site, Unlimited Medical Research (UMR). During its years of operation, UMR was engaged as a clinical trial site by a number of pharmaceutical companies. The conduct that led to the obstruction of justice charge stemmed from a clinical trial conducted at UMR to evaluate the safety and efficacy of a pediatric asthma drug.
Read more
Health Law Diagnosed — Mintz’s 2022 Health Law New Year’s Resolutions
January 12, 2022 | Podcast | By Bridgette Keller
In this episode of the Health Law Diagnosed podcast, members of the Mintz Health Law team discuss their health law–focused 2022 New Year’s resolutions and how they’re helping clients and colleagues navigate the continued challenges and opportunities of the current era.
Read more
An Overview of Pharmaceutical Sales Representative Licensure and Registration Laws in the United States
January 6, 2022 | Blog | By Jean D. Krebs, Joanne Hawana
On January 1, 2022, S.B. 763 took effect in Oregon, requiring pharmaceutical sales representatives (“PSR”) to obtain a license prior to marketing or promoting pharmaceutical products to health care providers. Oregon is not the first jurisdiction to enact such a law, but it is one of few jurisdictions in the United States to require licensure or registration of PSRs. This post discusses S.B. 763 and similar laws, regulations, and ordinances that are in effect in Nevada, Illinois, and Washington, D.C. below.
Read more
Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started
January 5, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.
Read more
About Face: Laboratory-Developed Tests for COVID-19 Now Subject to EUA Requirements
November 19, 2021 | Blog | By Joanne Hawana, Benjamin Zegarelli
For over a year now, there has been speculation about how the Biden Administration would handle the chronically vexing regulatory issues associated with laboratory-developed tests (LDTs). On November 15, 2021 we finally got our answer when the August 2020 policy put in place by the Trump Administration was officially withdrawn. The Food and Drug Administration (FDA) also released corresponding updates to various guidelines related to the testing response to the ongoing public health emergency. Before summarizing all of these critically important developments, we’ll provide some quick history of what has been going on with LDTs since the pandemic began.
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The End Is (Somewhat) Nigh: FDA Begins Rolling Back Enforcement Policies Implemented in Response to the COVID-19 Pandemic
November 16, 2021 | Blog | By Joanne Hawana
Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.
Read more
FDA Begins Modernizing its Resources and Implementing Over-The-Counter Monograph User Fee Requirements
October 14, 2021 | Blog | By Joanne Hawana
By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as part of the Coronavirus Aid, Relief, and Economic Security Act that was signed on March 27, 2020 (see our prior posts here and here).
As we’ve reported previously, at the end of 2020, the Office of Non-Prescription Drugs (ONP) of the Food and Drug Administration (FDA), launched a webpage for its brand new user Over-The-Counter Monograph User Fee Program (OMUFA) – available here – published programmatic fee rates for Fiscal 2021 (which ended on September 30, 2021), and subsequently posted a public arrears list of facilities that did not make their FY2021 facility payments as was required to be done by May 10, 2021. Drugs produced by those in-arrears facilities are considered misbranded under the law.
Read more
As we’ve reported previously, at the end of 2020, the Office of Non-Prescription Drugs (ONP) of the Food and Drug Administration (FDA), launched a webpage for its brand new user Over-The-Counter Monograph User Fee Program (OMUFA) – available here – published programmatic fee rates for Fiscal 2021 (which ended on September 30, 2021), and subsequently posted a public arrears list of facilities that did not make their FY2021 facility payments as was required to be done by May 10, 2021. Drugs produced by those in-arrears facilities are considered misbranded under the law.
FDA and FTC Coordination Appears to Be Escalating
September 15, 2021 | Blog | By Joanne Hawana
Agencies of the federal government with a consumer protection mission have always tended to work closely together and to share information, but the COVID-19 pandemic has made those cooperative efforts even more visible to the general public. We blogged in 2020 about the increasing use of warning letters jointly issued by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) Division of Advertising Practices in the apparently never-ending fight against fraudulent COVID-19 products (see prior post here). While coordinated FDA and FTC enforcement activities specific to the ongoing public health emergency continue at a brisk pace – as of September 9, 2021, FDA has issued more than 200 warning letters to companies claiming that a product is an effective cure, treatment, or preventative for COVID and the FTC has issued more than 400 pertaining to unsubstantiated health claims for COVID-related products, with many of those being signed by both agencies – these powerhouse regulators also appear to have become more comfortable with announcing joint actions in non-COVID contexts. This trend makes it even more important for manufacturers and marketers of consumer-facing products to be fully aware and compliant with all of their legal and regulatory obligations.
Read more
Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress
September 10, 2021 | Blog | By Joanne Hawana, Theresa Carnegie, Lauren Moldawer
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9, 2021. The Plan makes it clear that the Biden Administration supports aggressive action to address rising drug prices, including controversial actions such as allowing HHS to negotiate the cost of Medicare Part B and D drugs. The Plan also outlines a set of administrative actions that HHS and its operating agencies can take, without the need for intervention by Congress. A notable gap in the Plan, however, is the Administration’s potential approach to manufacturer rebates and the Rebate Rule.
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Ushering in a New Era: FDA Approves First Interchangeable Biosimilar
August 4, 2021 | Blog | By Joanne Hawana
Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee (insulin glargine) on July 28, 2021. Mylan’s Semglee is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is both biosimilar to and interchangeable with Lantus (insulin glargine) meaning it can be substituted for Lantus at the pharmacy-level without the need for a prescription from a healthcare professional. This approval is important because it furthers FDA’s commitment to supporting a competitive marketplace for insulin products. The availability of interchangeable biosimilar products can provide more treatment options to patients, lowering the treatment costs and enabling greater access for more patients. One can hope that this approval marks the beginning of a trend in the biosimilar marketplace.
Read more
News & Press
Charting A Year Of The Biggest COVID Scams Cited By FDA
March 15, 2021
Mintz Member Joanne S. Hawana was quoted in an analysis article published by Law360 on the biggest COVID-19 product scams and actions taken by the U.S. Food and Drug Administration (FDA) to tackle fraudsters during the ongoing crisis.
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
Mintz Members Brian P. Dunphy, Joanne S. Hawana, and Jennifer B. Rubin co-authored a Bloomberg Law insights column examining potential legal liabilities for employers implementing Covid-19 workplace vaccination programs, explaining that immunity under the federal Public Readiness and Emergency Preparedness Act (PREP Act) is not absolute.
User Fees Will Be A Focus For Senate HELP, No Matter Who’s In Charge
November 5, 2020
An article published by Inside Health Policy featured extensive commentary from Senior Director of ML Strategies Aaron Josephson on priorities for the Senate Health, Education, Labor and Pensions (HELP) Committee following the 2020 Presidential election. Mintz Member Joanne Hawana was also quoted in the article.
COVID-19: Regulators Confronted with Scourge of ‘Fake Cures’
September 29, 2020
Mintz Member Joanne Hawana was quoted extensively in an article published by the International Bar Association on how consumer protection bodies, including the U.S. Food and Drug Administration, are dealing with the proliferation of fake products and treatments related to COVID-19.
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
In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.
Mintz Member Joanne Hawana is quoted in an article published by MedCity News discussing the latest decision by the U.S. Food and Drug Administration (FDA) granting an emergency use authorization for hydroxychloroquine and chloroquine for COVID-19, and the balance the agency is taking with the current pandemic.
What FDA Has Done So Far In Response To COVID-19
April 1, 2020
Mintz Member Joanne Hawana, Senior Director of ML Strategies Aaron Josephson, and Mintz Associate Benjamin Zegarelli co-authored an article published in Law360 discussing the latest actions from the U.S. Food and Drug Administration (FDA) in response to COVID-19.
Mintz Promotes Eleven Attorneys to Member
May 10, 2019
FDA Finally Hitting Sweet Spot With Off-Label Oversight
November 21, 2018
This Law360 analysis piece looks at how the U.S. Food and Drug Administration (FDA) is easing concerns about off-label marketing restrictions without antagonizing the plaintiffs bar or public health advocates. FDA attorney Joanne Hawana is quoted providing third-party commentary in the piece.
MODERN Labeling Act Needs Liability Protection for Generics
November 14, 2018
This piece looks at what could make the proposed Making Objective Drug Evidence Revisions for New Modern Labeling (MODERN) Act stronger - primarily liability protection for generics. Joanne Hawana is among the FDA industry sources quoted providing commentary in the piece.
Cosmetic Companies Must Plan For New Regulation
December 14, 2017
Arameh O’Boyle, a Member and Nada Shamonki, Of Counsel in the Mintz Los Angeles office, and Joanne Hawana, Of Counsel in the firm’s Washington, DC office collaborated on an article published in Law360 on regulatory changes to the cosmetics and personal care products industries.
But What About Food? FDA Director Scott Gottlieb’s 4-month Scorecard
September 14, 2017
Mintz attorney Joanne Hawana authored an article published by ICIX assessing the performance of FDA Commissioner Scott Gottlieb’s first four months on the job.
Mintz Attorney Says New FDA Organizational Changes Could Have Big Food Industry Effects
July 5, 2017
The Food and Drug Administration quietly announced and enacted significant organizational changes. FDA and Health Law attorney Joanne Hawana is quoted in this article discussing the potential impacts of these changes could include faster FDA factory inspections and audits.
5 Ways Trump Could Change Food Safety Compliance
April 26, 2017
Joanne Hawana, an attorney in Mintz’s FDA and Fraud & Abuse, Compliance & Regulatory Counseling Practices, is included in this piece which discusses changes the Trump administration could make to Food Safety Compliance and the dangers of lawsuits against the government amid deregulatory efforts.
New FDA Enforcement Stats Show Shifting Targets
February 13, 2017
Health Law and FDA attorneys Bethany Hills and Joanne Hawana are among the industry sources quoted in this piece analyzing new statistics from the U.S. Food and Drug Administration showing a relatively quiet 2016, but a busier year for enforcement in 2017.
Will FDA Adverse Event Data Release Mean More Lawsuits?
January 18, 2017
In this Law360 feature article, Joanne Hawana and Dan Herling discuss the release of data regarding adverse events received by the FDA’s Center for Food Safety and Applied Nutrition, whether the timing of the release matters, and what greater AER transparency means for litigations risks.
The FDA targeted DTC, video, unapproved drug promotion in 2016
January 18, 2017
This article, published in Medical Marketing & Media, addresses the FDA’s new approach to regulating drugmakers’ advertising and promotion. Mintz FDA team members Bethany Hills and Joanne Hawana offer insight.
FDA Sticks to Its Naming Plan for Biologics and Biosimilars
January 13, 2017
This Bloomberg BNA Health Law article discusses the FDA's controversial guidance on the naming of biological products, designed to prevent inadvertent substitution and support safety monitoring when they are on the market.
Health Care Enforcement Review And 2017 Outlook: Part 1
January 13, 2017
Three attorneys from Mintz authored the initial installment of a four-part series recapping key government policies, regulations, and enforcement actions from 2016 and discussing their potential impacts on 2017.
FDA and Health Law attorney Joanne Hawana is quoted in this Medical Marketing & Media article on the FDA off-label hearing. The article discusses possible results from the hearing which could facilitate a regulatory resolution to the off-label pharmaceutical promotion issue.
Mintz Attorney Joanne S. Hawana to Speak at 2016 TEDCO Entrepreneur Expo
November 02, 2016
Joanne S. Hawana, Of Counsel for Mintz's Health Law Practice, is participating in two sessions at the 2016 TEDCO Entrepreneur Expo. The event will bring together entrepreneurs, business executives, investors, economic development officials, and legislators.
Why FSMA collaboration is the new normal in food transportation
November 1, 2016
FDA and Health Law attorney Joanne Hawana is quoted in this Refrigerated and Frozen Foods article on why frozen food manufacturers and grocery retails must remain diligent about checking that their safety procedures and policies still comply with best practices.
Providers, Pharmacists Call for Earlier FDA Guidance on Biosimilars
October 24, 2016
FDA and Health Law attorney Joanne Hawana is quoted in this Bloomberg BNA Health Care Policy Report article on how pharmacists and medical providers are calling upon the FDA for quick guidance on biosimilars.
Food Safety Regulations Will Affect California Tort Law
July 13, 2016
Dan Herling, a Litigation Member in the Mintz San Francisco office, and FDA attorney Joanne Hawana authored this San Francisco Daily Journal article covering the predicted impact of the FDA's food safety regulations on California tort law.
GE Salmon Sets Stage For Future GMO Labeling Regime
June 27, 2016
Health Law attorney Joanne Hawana and Associate Benjamin Zegarelli authored a Law360 column on how the Senate Appropriations Committee’s approval of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2017 appropriations bill sets the stage for GMO legislation.
Food Companies Are Hedging Their Bets With GMO Labeling
April 25, 2016
FDA and Health Law attorney Joanne Hawana and New York Associate Benjamin Zegarelli authored this Law360 column discussing the growing public support for genetically modified organism and genetic engineering labeling on appropriate food products across the board.
The Parental Drug Association (PDA) has published a book by Washington, D.C. FDA and Health Law attorney Joanne Hawana. According to the PDA, the book “presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions.”
FDA and Health Law attorney Joanne Hawana is quoted in this Medical Marketing and Media article on how despite calls for change from pharmaceutical marketers, it is not likely that limitations on direct-to-consumer practices will become a reality.
Events
Moderator
Mar
8
2022
DIA Advertising and Promotion Regulatory Affairs Conference
Drug Information Association (DIA)
Arlington, VA
Speaker
Speaker
Oct
25
2021
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
Speaker
Jun
17
2021
US Regulation of Advertising, Promotion and Labeling for Medical Devices
Regulatory Affairs Professional Society (RAPS)
Online Event
Panelist
Jun
8
2021
Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies
Food and Drug Law Institute
Online Event
Moderator
Speaker
Jan
15
2021
Mandatory or Voluntary Workplace Vaccination – Guidance for Employers
This is an online event.
Oct
8
2020
Food and Drug Law Institute Annual Conference
FDA’s Amended Intended Use Regulation – Has It Finally Hit the Sweet Spot?
Online Event
May
18
2020
DIA Advertising and Promotion Regulatory Affairs Conference
Engaging with Patients to Diversify Advertising and Promotional Activities
Online Event
Speaker
Apr
7
2020
Everything Life Sciences Companies Need to Know to Navigate the COVID-19 Pandemic
View the Webinar Recording
Mar
31
2020
Introduction to Biologics and Biosimilars Law and Regulation Course Presented by FDLI
Regenerative Medicine Advanced Therapies (RMATs)
Jan
15
2020
ELabs NYC
Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies
New York, NY
Panelist
Sep
24
2019
Six-Month Assessment: The Impact of Gottlieb’s Departure on FDA Priorities
Mintz, 3580 Carmel Mountain Road | Suite 300, San Diego, CA
Speaker
Jun
20
2019
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
Moderator
May
3
2019
Food and Drug Law Institute Annual Conference
Regenerative Medicine, Gene Therapies, and FDA Regulation
Washington, DC
Speaker
Speaker
Speaker
Feb
6
2019
FDLI's Introduction to Drug Law and Regulation Course
Regulation of Over-the-Counter OTC Drugs
Lake County, Illinois
Speaker
Jan
16
2019
ELabs NYC
Planning for Success: Integrating Product Development with Intellectual Property and Regulatory Strategies
New York, NY
Moderator
Nov
13
2018
Drug Compounding Post-DQSA: Emerging Regulatory Challenges & Business Opportunities
Mintz, One Financial Center, 38A, Boston, MA 02111
Speaker
Nov
6
2018
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.
Moderator
Speaker
Faculty
Moderator
Speaker
Panelist
Speaker
Nov
10
2016
Speaker
Aug
9
2016
Compounding Under Sections 503A and 503B: Distinctions, Limitation, Liabilities, and Compliance
FDANEWS
Webinar
Speaker
Panelist
Aug
5
2015