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Thinking Post-COVID: How Will US FDA Transition Drug, Vaccine EUAs To Full Approvals?

Sponsors seek clarity about the transition process, which could last a year or longer.

Coronavirus COVID-19 Review Pathway

Remdesivir EUA Includes Promotional Limitations Absent From Chloroquine Authorization

Printed materials and promotions must describe Gilead’s drug as authorized, not approved, for treating COVID-19; although similar boilerplate restrictions are part of most of the EUAs issued for diagnostics and equipment to combat the novel coronavirus, they were not included in the authorization for chloroquine/hydroxychloroquine. Remdesivir's new website strongly resembles an approved brand product site.

Advertising, Marketing & Sales Coronavirus COVID-19

As Chloroquine Demand Surges, Bayer Looks To Emergency Use Authorization To Enter US Market

Unlike diagnostics, EUAs for drugs are rare and the fact that there already are FDA-approved competitors for Bayer’s chloroquine phosphate product may make the decision more complicated.

Coronavirus COVID-19 Review Pathway

Deals Shaping the Medical Industry, September 2016

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in August 2016.

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