Law – Medical Alley Association

Law

For the Record with Amanda Johnston, Managing Attorney, Gardner Law, PLLC

Amanda Johnston, J.D., R.A.C., Managing Attorney at Gardner Law, PLLC, specializes in counseling medical technology and pharmaceutical companies on FDA law, regulatory submissions and strategy, healthcare compliance programs, and fraud and abuse laws. Amanda has worked on 100+ FDA submissions, including PMAs, 510(k)s, HDEs, IDEs, NDAs, Pre-Submissions (Q-Subs), Breakthrough Designations, De Novos, RFDs, EUAs, change […]

Legal Issues Affecting Supply Chain

This new series of articles, brought to you by the attorneys at Stinson Leonard Street LLP in partnership with the Medical Alley Association, provides thoughtful analysis of privacy obligations, licensing compliance, transparency and gift ban statutes, data rights and other legal issues that can have a significant impact on life sciences companies. The Clinical Stage is the Critical […]

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