USA – Moderna chairman says COVID-19 vaccine could begin phase 2 trials in spring

Moderna’s chairman Noubar Afeyan has said that phase 2 human trials of the company’s coronavirus vaccine could begin in spring, as pressure mounts for...
FDA: 2019 Continues Uptick in Orphan Drug Approvals

USA – Why FDA’s Issuance of EUAs are Not ‘Approvals’ and Why That Matters

You may have read that some drugs are now “approved” to treat COVID-19, or as the New York Times reported yesterday, that the US Food and...
Coronavirus delays many FDA foreign inspections

USA – FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately....
Safety testing for coronavirus vaccine begins

USA – COVID-19 Therapeutics Tracker

As COVID-19 continues to spread around the globe, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. In the US,...

USA – Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section...

In light of the Coronavirus Disease 2019 (COVID-19) public health emergency, this guidance is being implemented without prior public comment in accordance with 21...

USA – Gilead’s withdrawal of orphan status of COVID-19 candidate

Gilead Sciences' investigational antiviral drug remdesivir has been saddled with high hopes as drugmakers search for a possible COVID-19 treatment. But after the FDA made...

USA – FDA, Grifols to develop plasma therapeutics for COVID-19

Spain’s Grifols has agreed to work with the U.S. Food and Drug Administration and other agencies to gather plasma from patients who have recovered...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

USA – Convalescent Plasma: FDA Facilitating Emergency Access

One potential treatment for COVID-19, known as convalescent plasma, may be derived from patients who have already recovered from the disease, and the US Food...

International – FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development

Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed to it. They have been highly effective...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – FDA: No clear proof NSAIDS can worsen COVID-19

The Food and Drug Administration (FDA) has issued a statement regarding the use of nonsteroidal anti-inflammatory drugs (NSAIDS) in patients with coronavirus disease 2019...