Amy K. Dow

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Epstein Becker & Green, P.C.

 

 

AMY K. DOW is an Associate in the Health Care and Life Sciences practice, in the firm’s Chicago office.

Ms. Dow:

  • Counsels clients regarding the research, approval, sale and promotion of pharmaceuticals, biologics and medical devices
  • Drafts and negotiates agreements with providers of clinical and non-clinical development services
  • Counsels clients regarding fraud and abuse issues associated with pharmaceutical and medical device development and marketing activities
  • Develops good promotional practices and other policies and procedures related to pharmaceutical and medical device development and marketing activities
  • Conducts health regulatory due diligence for transactions in the life sciences industry

Prior to joining the firm, Ms. Dow was a Senior Clinical Research Associate at a large contract research organization, where she monitored Phase II, III, and IV pharmaceutical clinical trials.

ARTICLES

06/30/10 – Chapter 10, “Payment to Research Subjects,” in Institutional Review Boards: A Primer, Second Edition

01/20/10 – Try It Before You Buy It: Maximizing Buyer Opportunities in Healthcare Regulatory Due Diligence Reviews of Life Sciences Companies as appeared in Journal of Health & Life Sciences Law

CLIENT ALERTS

10/13/2011 – The Department of Health and Human Services Requests Comments on Proposed Changes to the “Common Rule”

8/15/2011 – Maine Repeals Pharmaceutical Disclosure Requirements Related to Marketing Costs, Drug Pricing, and Clinical Trials

2/1/2010 – Clinical Research Regulatory Update: FDA Proposes Updates To Informed Consent Regulations, Issues Guidance On IRB Continuing Review

10/2/2009 – Vermont Bans Gifts and Expands Disclosure Requirements for Payments to Health Care Providers

12/23/2008 – FDA & OHRP Guidance on Data Retention and Other Considerations Applicable to Subjects Who Withdraw From Clinical Research

3/5/2008 – FDA Issues Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses

8/4/2005 – SPECIAL ALERT: Supreme Court Clarifies, and Seems to Weaken, Patent Rights in Pharmaceutical Compounds

EVENTS

02/27/07 – Master Class on Managing Legal Risks in Structuring & Conducting International Clinical Trials

One response to “Amy K. Dow

  1. Pingback: Attacks on FDA’s Aggressive Stance: Off vs. On-Label | Good Promotional Practices

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