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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

Publication/Podcast

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...

Publication/Podcast

Massachusetts Health Care Bill Makes Several Significant Changes

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...

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.

News

Verrill Ranked in American Bar Association’s Health Law Top 10 in the Northeast

(January 19, 2021) – Verrill was recently ranked third in the American Bar Association (ABA) Health Law Section's Eighth Annual Top 10 Recognition for the Northeast Region. This is the sixth consecutive year that...

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

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...

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

Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.

Health care attorney Paul Shaw co-authored Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition with Robert Griffith, published by the American Health Law Association (AHLA). Paul and Robert provide legal...

Matter

Conflicts of Interest

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

News

Verrill Welcomes Health Care Attorney Alicia Siani

(February 2, 2021) – Verrill is pleased to welcome health care attorney Alicia Siani to the firm’s Boston, Massachusetts office. Siani represents clients in a wide range of regulatory issues, including HIPAA privacy matters...

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