Title: Navigating Uncharted Waters. Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

For researchers involved in the development of new treatments and vaccines to combat COVID-19, the past five months have been a scramble to research potential therapies, collect and analyze data, accelerate clinical trials, and plan manufacturing processes. While the biopharma industry knows these development efforts are moving at record pace, for some patient groups, policymakers, and the public, the efforts are not moving fast enough. When someone is seriously ill, family members and healthcare providers are desperate for an effective treatment. History has shown that many “promising” therapies initially raised the hopes of patients, only to disappoint when the therapy did not work as predicted. During this global pandemic, public and policymaker pressure can make the R&D task more difficult.

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   Person Information
   Application Sequencing
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • Food & Drug Adminstration

  • Risk Assessment

 

  • Regulations & Policy/Regulations

  • Standards

 

 

 

  • Pharmaceutical Technology

 

  • 7/1/2020

 

  • Article