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Verrill Dana Welcomes Former FDA Counsel Katlin McKelvie Backfield

July 11, 2018 Press Releases

(July 11, 2018) – Verrill Dana is pleased to welcome attorney Katlin McKelvie Backfield to the firm's nationally recognized Health Care Group. Katlin comes to Verrill Dana with more than 15 years of pharmaceutical regulatory experience, including more than a decade at the Food and Drug Administration.

While at the FDA, Katlin served as Associate Chief Counsel for Drugs in the Office of Chief Counsel and as a Regulatory Counsel in the Division of Drug Marketing, Advertising, and Communications (DDMAC) (now the Office of Prescription Drug Promotion). Prior to joining the FDA, she practiced at Hogan & Hartson LLP (now Hogan Lovells LLP).

Katlin's in-depth experience at the FDA and in private practice will be a valuable asset to the Health Care Group's thriving life sciences and clinical research practice areas. She helps clients navigate the complex pre- and post-approval stages of drug development and address high-stakes FDA regulatory compliance matters. Katlin's areas of focus include, among others, advertising and promotion, manufacturing and inspections, the drug development process (including INDs, BLAs, and NDAs), and post-marketing safety requirements.

Katlin served as a law clerk for the Honorable Douglas P. Woodlock of the U.S. District Court for the District of Massachusetts. She received her law degree from the Georgetown University Law Center and earned her bachelor's degree from Davidson College.

Firm Highlights

News

Michael K. Fee to Lead Verrill’s Nationally-Recognized Health Care and Life Sciences Practice Amidst Recent Changes

(August 31, 2020) – Verrill is pleased to announce Michael K. Fee as the new leader of Verrill’s nationally-recognized Health Care & Life Sciences Group. The Group has a long history of representing a...

News

Nearly 80 Verrill Attorneys Recognized by Best Lawyers® 2021, Including a Dozen Named Lawyers of the Year

(August 24, 2020) – Nearly 80 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2021 , including 12 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer...

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Publication/Podcast

Hospital Price Transparency Rule: Full Steam Ahead

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services ( CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should...

Matter

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...

Publication/Podcast

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory...

Matter

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

Publication/Podcast

“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments

Publication/Podcast

EU-U.S. Privacy Shield Invalidated: Does Your Company Have a Plan B?

On Thursday, July 16, 2020, the Court of Justice of the European Union (“CJEU”) invalidated the EU-U.S. Privacy Shield (“Privacy Shield”) in Data Protection Commissioner v. Facebook Ireland and Maximillian Schrems (Case C-311/18...

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