ANVISA: actions related to COVID-19

  • General actions:

The Brazilian National Regulatory Authority, Anvisa, is carrying out several regulatory and informative actions to address the international public health emergency related to SARS-CoV-2 (a new type of coronavirus), which causes COVID-19. All related information is gathered on the link:

Report on ANVISA’s actions to fight the pandemic  (NEW)

  • IVD for COVID-19

The COVID-19 IVD  list is daily updated and is available here 

  • Regulations and guidance:

The list of specific regulations and guidance is regularly updated and available at


FDA: COVID-19 regulatory update



USP: resources and information related to COVID-19

The United States Pharmacopeia (USP) has made available some resources and information related to COVID-19 to the public:




COVID-19 guidance and ongoing research in the Americas

Healthcare business graph and Medical examination and businessman analyzing data and growth chart on blured background


PAHO has developed a searchable database that provides access to technical guidelines, scientific publications, and ongoing research protocols from the Americas and affected countries worldwide regarding the coronavirus disease (COVID-19) pandemic.

Recommendations and guidance from the Pan American Health Organization and the World Health Organization are also included, making it a useful platform of trusted information for decision and policy-making authorities, researchers, health professionals, and individuals.

Click here to access the page


FDA: actions related to COVID-19


PAHO: Ethics guidance on issues raised by the novel coronavirus disease (COVID-19) pandemic 


PAHO’s Regional Program on Bioethics has developed a document that provides ethics guidance for the public health response, health care delivery and research during current COVID-19 pandemic.

Such document is available at:

In the virtual seminar to PAHO’s ethics guidance for COVID-19 research was presented the imperatives to conduct rapid ethics review of COVID-19 research protocols and to promote future research through the use of broad consent were discussed.  The recording is available at:


FDA: Investigational COVID-19 Convalescent Plasma – Emergency Investigational New Drug Applications

Investigational COVID-19 Convalescent Plasma – Emergency INDs

FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization. This does not include the use of COVID-19 convalescent plasma for the prevention of infection.

Click here to access the complete information.


Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level.
Additional information: