2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir served as acting interim commissioners following Commissioner Gottlieb’s resignation. On December 17, Congress swore in Commissioner Stephen Hahn, a radiation oncologist and former chief executive of MD Anderson Cancer Center.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year, and offers insight into the agency’s 2020 priorities and expected actions in a number of areas, including:

  • Digital health;
  • Streamlined product approvals;
  • Evolving evidentiary thresholds for product approvals;
  • Strategic enforcement;
  • And much more.

Click here to read the full report. 

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Photo of Vernessa T. Pollard Vernessa T. Pollard

Vernessa T. Pollard advises companies on regulatory, compliance, enforcement and policy matters involving pharmaceuticals, medical devices, health information technology (HIT) and digital health solutions, services and software. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions and other…

Vernessa T. Pollard advises companies on regulatory, compliance, enforcement and policy matters involving pharmaceuticals, medical devices, health information technology (HIT) and digital health solutions, services and software. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions and other transactions involving Food and Drug Administration (FDA)-regulated products. She also counsels manufacturers, distributors and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety. Read Vernessa Pollard’s full bio.

Photo of Michael Ryan Michael Ryan

Michael W. Ryan advises manufacturers, health care providers, developers, and investors on the legal, regulatory, and reimbursement issues that arise during the development and commercialization of medical devices, drugs, biological products, and clinical laboratory testing services. Read Michael Ryan’s full bio.

Alva C. Mather

Alva C. Mather focuses her practice on alcohol beverage and cannabis regulatory and commercial matters. She represents companies in the alcohol beverage industry, including brewers, distillers, wineries, importers and retailers. Additionally, she works with clients in the growing cannabis space and has in-depth…

Alva C. Mather focuses her practice on alcohol beverage and cannabis regulatory and commercial matters. She represents companies in the alcohol beverage industry, including brewers, distillers, wineries, importers and retailers. Additionally, she works with clients in the growing cannabis space and has in-depth knowledge of the evolving legal and regulatory issues facing this industry. Read Alva Mather’s full bio.

Photo of Anisa Mohanty Anisa Mohanty

Anisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing…

Anisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Read Anisa Mohanty’s full bio.

Photo of Gugan Kaur Gugan Kaur

Gugan Kaur advises life sciences clients on Food and Drug Administration (FDA) regulatory, compliance and enforcement issues. She provides counsel on matters throughout the product development process, including clinical trials, labeling and advertising, post-marketing, FDA inspections, and compliance and enforcement actions. She also…

Gugan Kaur advises life sciences clients on Food and Drug Administration (FDA) regulatory, compliance and enforcement issues. She provides counsel on matters throughout the product development process, including clinical trials, labeling and advertising, post-marketing, FDA inspections, and compliance and enforcement actions. She also advises clients on potential Federal Trade Commission (FTC) issues related to FDA-regulated products. Gugan has experience assisting clients in submitting trade complaints to FDA, FTC, the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP). Read Gugan Kaur’s full bio.