FDA Outlook for 2022

The US Food and Drug Administration (FDA) continues to juggle enormous Covid-related responsibilities, while simultaneously attempting to make progress on a huge number of important regulatory priorities and programs that are either in need of reform or in the midst of active reform at the agency or at the legislative level. President Biden’s first Senate-confirmed FDA Commissioner is also expected to take the reins in early 2022 and has promised to re-evaluate several challenging areas for the agency, from the labeling for FDA-approved prescription opioids to the proliferation of medical misinformation and false product claims on social media. Among so much other priority work, the Center for Devices and Radiological Health released its first guidance on the process for transitioning emergency-authorized devices and diagnostic tests to “full” clearance or approval at the end of December 2021, finalized De Novo classification process regulations earlier in the year, and has promised to publish a proposed rule to harmonize the Quality System Regulation with ISO 13485:2016 any day now. 

Join Joanne Hawana and Benjamin Zegarelli, FDA regulatory attorneys from Mintz, 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. 

Webinar topics will include:  

• Update on the 2022 User Fee agreements recently negotiated with industry 
• Current status of FDA’s oversight of in vitro diagnostics, including Covid-19 tests, and prospects for legislative reform in this area
• Summary of the agency’s acceptance of RWE/RWD for drug and device applications and potential additional mandates it may be tasked with via the 2022 User Fee Reauthorization bills or the Cures 2.0 package   
• How likely FDA is to maintain the clinical trial flexibilities that were put in place due to the Covid pandemic, including options for remote monitoring of study participants    
• Whether inspectional backlogs caused by the pandemic are likely to be abated in the near future 
  
  

Joanne S. Hawana | Member | Mintz

Joanne Hawana is a Member of the law firm Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, practicing in the Health/FDA Group and based in the firm’s Washington D.C. office. She counsels global clients on the business impact of new U.S. federal and state actions related to drugs, biologics, cellular therapies, foods, and medical devices. Her 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 compliance requirements; and enforcement-related matters. She also provides regulatory expertise to her colleagues in class action and other litigation involving FDA-regulated products, and she works with the Mintz Corporate & Securities Practice on transactions and offerings for companies regulated by the FDA. Joanne has a masters degree in molecular genetics from UMDNJ and a bachelors degree in biology from the College of William & Mary. She received her JD from the University of Maryland Francis King Cary School of Law in 2007. 

Benjamin M. Zegarelli | Of Counsel | Mintz

Benjamin Zegarelli is Of Counsel at the law firm Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, practicing in the Health/FDA Group and based in the firm’s New York office. He provides counsel to a breadth of health care industry clients, including pharmaceutical, medical device, and bio tech companies, on the federal and state laws surrounding medical product development and marketing. In particular, Benjamin has extensive experience guiding medical device companies through the FDA regulatory process to identify the correct regulatory pathway, assisting with communications and meetings with FDA, ensuring that regulatory submissions meet regulatory requirements, and helping to establish robust post-market quality system and compliance controls. His practice also includes representing both clinical trial sponsors and clinical sites on clinical research issues, including government grant regulations, as well as drafting and negotiating the agreements necessary to perform clinical research. Benjamin has a masters degree in organic chemistry from the California Institute of Technology and a bachelors degree in chemistry from Middlebury College. He received his JD from the Benjamin N. Cardozo School of Law in 2013.