COVID-19 | FDAnews

HHS Gives Liability Cover for Coronavirus Countermeasures

March 23, 2020

A manufacturer creating a vaccine will be exempt from liability claims alleging negligence. Read More

FDA Says No Evidence NSAIDs Aggravate COVID-19 Symptoms

March 23, 2020

The Medicines and Healthcare Products Regulatory Agency also said Friday that there is currently no research linking ibuprofen to the likelihood of contracting the virus or worsening the symptoms. Read More

Lucence Working on Coronavirus Sample Collection Device

March 20, 2020

Ideally, samples should be transported in a chilled medium, but this is not always possible. Read More

Rheonix Seeks Emergency Authorization for COVID-19 Test

March 20, 2020

The cartridge-based system reduces sample handling time. Read More

Carbon Health Ships Home COVID-19 Tests to California Patients

March 20, 2020

The kits should reduce the strain on clinics and prevent non-infected individuals from exposing themselves to the virus, the company said. Read More

Qiagen Snags CE Mark for Coronavirus Diagnostic

March 19, 2020

The multiplex nucleic acid test is the first syndromic testing solution cleared in the EU, the company said. Read More

FDA Suspends Domestic Inspections as Coronavirus Outbreak Spreads

March 19, 2020

All eligible FDA employees are now teleworking. Read More

Abbott’s Coronavirus Test Earns Emergency Clearance

March 19, 2020

Abbott will distribute 150,000 tests immediately and aims to provide up to one million tests per week. Read More

Emergent BioSolutions to Develop Two COVID-19 Treatments

March 19, 2020

COVID-EIG will use plasma of immunized horses with antibodies to the virus as a potential treatment for severe hospitalized patients. Read More

Becton Dickinson, BioGX Seek FDA Emergency Clearance for COVID-19 Tests

March 18, 2020

The tests would increase the potential capacity to screen for COVID-19 by thousands of tests per day, BD said. Read More

FDA Clears Two More Coronavirus Diagnostics for Emergency Use

March 17, 2020

More than 90 diagnostic developers have contacted the FDA seeking guidance on coronavirus test development and validation, the agency said. Read More

European Commission to Fund Diagnostics Research to Tackle COVID-19

March 16, 2020

“As cases continue to rise, public health is the number one priority,” said the commission’s President Ursula von der Leyen. Read More

COVID-19
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HHS Gives Liability Cover for Coronavirus Countermeasures

FDA Says No Evidence NSAIDs Aggravate COVID-19 Symptoms

Lucence Working on Coronavirus Sample Collection Device

Rheonix Seeks Emergency Authorization for COVID-19 Test

Carbon Health Ships Home COVID-19 Tests to California Patients

Qiagen Snags CE Mark for Coronavirus Diagnostic

FDA Suspends Domestic Inspections as Coronavirus Outbreak Spreads

Abbott’s Coronavirus Test Earns Emergency Clearance

Emergent BioSolutions to Develop Two COVID-19 Treatments

Becton Dickinson, BioGX Seek FDA Emergency Clearance for COVID-19 Tests

FDA Clears Two More Coronavirus Diagnostics for Emergency Use

European Commission to Fund Diagnostics Research to Tackle COVID-19

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The Revised ICH E8: A Guide to New Clinical Trial Requirements

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