Revocation of EUA for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19

FDA believe’s the suggested dosing regimens for CQ and HCQ unlikely to produce an antiviral effect

  • Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated
  • Recent data from a randomized controlled trial showed no difference between HCQ vs. standard of care slone
  • Current U.S. treatment guidelines do not recommend the use of CQ or HCQ outside of a clinical trial; NIH guidelines now recommend against such use outside of clinical trial
  • Recent data from a large randomized controlled trial with HCQ showed no evidence of benefit for mortality or hospital length of stay or need for mechanical ventilation
  • Additionally, the serious cardiac adverse events and other serious side effects cause the risks to outweigh benefits

Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate (PDF, 125 KB)


Development and Licensure of COVID-19 vaccine

Recommendations :

  • Using different technologies such as DNA, RNA, protein and viral vectored vaccines
  • Help expedite vaccine development without sacrificing our standards for quality, safety, and efficacy
  • Guidance provides overview of key considerations chemistry, manufacturing and control, nonclinical and clinical data
  • Studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease

Final Guidance

Partnering with the European Union and Global Regulators on COVID-19

FDA, European Commission (EC) and European Medicines Agency (EMA) have a multitude of critical scientific and regulatory collaborations for COVID-19 response  

  • 30 technical expert groups, or “clusters”
  • Exchanging information on interpretation of data supporting regulatory decisions
  • Virtual bilateral meetings to review high-priority areas
  • Engagement with global regulators, under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe
  • International collaborations in medical device work
  • READ

Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

Hand sanitizer products containing methanol, or wood alcohol

  • Often used to create fuel and antifreeze
  • Can be toxic when absorbed through the skin as well as life-threatening when ingested
  • Reported recent adverse events from adults and children including blindness, hospitalizations and death


Webpage for a full list of FDA-tested and recalled hand sanitizers:

Image credit: FDA