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
FDA and FTC Coordination Appears to Be Escalating
September 15, 2021 |Blog
Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress
September 10, 2021 |Blog
News & Press
Events
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.
Joanne Hawana will be speaking on a panel of experts at the 2021 Springboard Enterprises Life Sciences program by SBE Australia on September 23. The session will be focused on regulatory and compliance issues facing the healthcare and life science industries.
Joanne Hawana will be speaking on a session titled, "Navigating Federal Trade Commission (FTC) Requirements for Medical Devices," at the US Regulation of Advertising, Promotion and Labeling for Medical Devices RAPS Conference
Viewpoints
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.
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Bipartisan VALID Act Re-Introduced in Congress: Is Diagnostics Reform on the Horizon?
July 13, 2021 | Blog | By Joanne Hawana, Benjamin Zegarelli
In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical laboratory testing in general during the COVID-19 public health emergency. We highlighted at the time an August 2020 Trump Administration order barring FDA from requiring premarket review for any LDT unless the agency goes through formal rulemaking procedures. We also speculated that although “the regulatory framework and policies surrounding LDTs will be a prominent topic of debate in 2021…there will be no quick resolution of these issues, either at a legislative or agency policy level, in the short term and that LDTs will likely remain in a gray area of FDA regulation and policy for the foreseeable future.”
Read more
FDA’s Unapproved Drugs Initiative Revived, with Gusto!
June 7, 2021 | Blog | By Joanne Hawana
Although we’ve now entered June of 2021 and President Biden has yet to nominate someone to serve as the Commissioner of Food and Drugs, current Acting Commissioner Janet Woodcock and her Senate-confirmed boss, Department of Health and Human Services (HHS) Secretary Xavier Becerra, have wasted no time reviewing and revoking regulatory actions implemented in the waning days of the prior Administration’s tenure in charge of the Executive Branch. As we reported in April, the two leaders co-signed a decision to reverse January 2021 actions by the Trump Administration to exempt a large number of medical device types from Food and Drug Administration (FDA) premarket review, noting in their rationale that not only was FDA not consulted in the prior action but HHS’s original determinations “lacked adequate scientific support, contained multiple errors, and were ultimately flawed.”
On May 27, a similar reversal notice with strikingly similar language about the lack of FDA input or the inclusion of appropriate regulatory expertise in the decision-making process – and once again co-signed by Secretary Becerra and Dr. Woodcock – was published in the Federal Register. The target this time was the prior Administration’s announcement in November 2020 that it was withdrawing all FDA guidance documents prepared and issued as part of the agency’s Unapproved Drugs Initiative (UDI) and terminating the UDI program; that termination notice cited drug costs and competition-related concerns as well as the FDA’s failure to develop and announce the UDI through notice-and-comment rulemaking. We discussed this surprise action by the prior HHS leadership in our 2020 year-in-review blog post and speculated whether a more consumer-protective Department led by Secretary Becerra would be likely to reverse course (see here).
Read more
On May 27, a similar reversal notice with strikingly similar language about the lack of FDA input or the inclusion of appropriate regulatory expertise in the decision-making process – and once again co-signed by Secretary Becerra and Dr. Woodcock – was published in the Federal Register. The target this time was the prior Administration’s announcement in November 2020 that it was withdrawing all FDA guidance documents prepared and issued as part of the agency’s Unapproved Drugs Initiative (UDI) and terminating the UDI program; that termination notice cited drug costs and competition-related concerns as well as the FDA’s failure to develop and announce the UDI through notice-and-comment rulemaking. We discussed this surprise action by the prior HHS leadership in our 2020 year-in-review blog post and speculated whether a more consumer-protective Department led by Secretary Becerra would be likely to reverse course (see here).
Health Law Diagnosed — Hot Topics in FDA Regulation and Enforcement
May 12, 2021 | Podcast | By Joanne Hawana, Benjamin Zegarelli
This past year has been a busy one for the FDA, but it hasn’t all been about the pandemic.
Read more
FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results
May 6, 2021 | Blog | By Joanne Hawana
The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area since the requirements were created by Congress in 2007, hindering the clinical trial transparency promised to the public. However, there may be a shift in the lackadaisical enforcement over such reporting. On April 28, 2021, Acting FDA Commissioner Janet Woodcock, M.D., announced that that the agency had sent more than 40 pre-notices to sponsors of clinical trials for failing to submit required clinical trial results to ClinicalTrials.gov. Notably, a Notice of Noncompliance was issued for the first time.
Read more
FDA Releases Ambitious Action Plan for Further Reducing Children’s Exposure to Toxic Elements from Foods
April 28, 2021 | Blog | By Joanne Hawana, Jane Haviland, Caitie Hill
The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the adulteration of a food that “contains any poisonous or deleterious substance which may render it injurious to health.” As science and technology advance, so too does our collective understanding of what that famous statutory phrase from the Food, Drug, and Cosmetic Act should mean. Accordingly, FDA’s mission in overseeing the safety of the food supply is constantly subject to change. One excellent example of that is playing out in real time, because due to enhanced methods of detecting toxic elements in food, consumer interest groups and Congress have raised questions about FDA’s apparent lack of interest in looking for potential contaminants in our foods (even as available data show that the levels of some metals, like lead, have been in a general decline in the food supply as manufacturing also becomes more sophisticated and controlled and industry invests in better detection methods in the advancement of the shared goal of food safety).
Read more
FTC Engages in First Enforcement Action under COVID-19 Consumer Protection Act
April 27, 2021 | Blog | By Joanne Hawana, Samantha Kingsbury
In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19 Consumer Protection Act (the COVID-19 Act) and the Federal Trade Commission Act (FTC Act). The Commission’s allegations focus on the deceptive marketing of products containing Vitamin D and Zinc as being scientifically proven to treat or prevent COVID-19 and as being equally as effective as or more effective than currently available COVID-19 vaccines.
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.
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.
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.
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 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.
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
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