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 Stage
Making it to the clinical trial stage is an exciting milestone in the development of a new drug or device. To conduct the clinical trials required for FDA approval— and necessary for further development and refinement of the drug or device — most companies will need to contract with several clinical sites. Laura Nelson of Stinson Leonard Street LLC examines all that must be considered during this period in “The Clinical Stage is the Critical Stage.”
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Reducing Risk in Field Sales Operations
Field sales employees are critical to distribution and ultimately achieving revenue goals. However, the inability of employers in the supply chain to directly supervise field sales employees can create under-appreciated risks. Kristin Berger Parker of Stinson Leonard Street LLP details these risks, and how to mitigate them in “Reducing Risk in Field Sales Operations,” available at the link below.
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Can Off-Label Use Trigger A New Filing? FDA Still Not Sure
On January 12, 2018, U.S. Food & Drug Administration Commissioner Scott Gottlieb announced FDA’s intention to once again postpone its final rule amending the drug and device intended use regulations. This time, the ruling was postponed indefinitely. These regulations define the types of evidence FDA will use to determine a product’s intended use, which influences whether FDA will see a manufacturer as marketing an unauthorized (and therefore misbranded) product. Tricia Kaufman of Stinson LLP examines the effect of theses new regulations in the latest Legal Issues Affecting Supply Chain article.
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State Transparency and Gift Ban Statutes
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Wholesale Distributor Licenses
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Technology Transfer Deals
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