COVID-19 News
Cerneos Podcast – What Life Science Entrepreneurs can learn from the COVID-19 Pandemic
State of Massachusetts COVID Breakthrough cases:
https://www.nbcboston.com/news/local/breakthrough-covid-cases-in-mass-now-approaching-30000/2492577/
State of Massachusetts COVID Data – Resources:
https://www.mass.gov/covid-19-updates-and-information
Industrial Hygiene AIHA – COVID Resources
https://www.aiha.org/public-resources/consumer-resources/coronavirus_outbreak_resources
Industrial Hygiene AIHA – Respiratory Protection Standards for masks and respirators
OSHA standards and guidance on COVID respiratory protection
https://www.osha.gov/sites/default/files/respiratory-protection-covid19-compliance.pdf
Health Canada – Medical Device Authorizations related to COVID
Medical devices for expanded COVID-19 use: Authorized medical devices – Canada.ca
NIOSH – Respiratory protective devices for emergency use
NIOSH – Avoiding counterfeit respirators
https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
COVID-19 RESEARCH
FDA-COVID-19 Vaccine Safety
EMA – Management of clinical trials during COVID-19 Pandemic
NIAID – Research on Coronaviruses
https://www.niaid.nih.gov/diseases-conditions/coronaviruses
CDC RNA Vaccines
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mRNA.html
Information on SARS-Cov-2 variant:
Baric, Ralph, S. Ph.D., Clinical Implications of Basic Research – Emergence of a Highly Fit SARS-CoV-2 Variant. New England Journal of Medicine 383:27 December 31, 2020.
https://www.nejm.org/doi/full/10.1056/NEJMcibr2032888
World Health Organization (WHO)
https://www.who.int/emergencies/diseases/novel-coronavirus-2019
Centers for Disease Control and Prevention (CDC)
https://www.cdc.gov/coronavirus/2019-ncov/index.html
National Association of County and City Health Officials (NACCHO) – Public Health Information
https://www.naccho.org/novel-coronavirus-2019-covid-19
National Institute for Allergy and Infectious Diseases (NIAID)
Professional Organizations
Regulatory Affairs Professionals Society (RAPS) http://www.raps.org/
International Society for Pharmaceutical Engineering – ISPE http://www.ispe.org/
BIO International https://www.bio.org/
Mass Bio https://www.massbio.org/
National Association of Community Health Centers (NACCHO) Https://naccho.org
Regulatory Resources
Food and Drug Administration (FDA) http://www.fda.gov/
US Surgeon General https://www.hhs.gov/surgeongeneral/index.html
Centers for Disease Control and Prevention –(CDC) https://www.cdc.gov/
FDA Device Advice: http://www.fda.gov/medicaldevices/deviceregulationandguidance/default.htm
FDA Expedited Access Program – EAP http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm441467.htm
Department of Health and Human Services – https://www.hhs.gov/
HHS Employee Directory – http://directory.psc.gov/employee.htm
FDA 510(k) Searchable Database – https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
International Resources
British Consulate- Boston https://www.gov.uk/government/world/organisations/british-consulate-general-boston
European Association for Lexicography http://euralex.org/
European Union https://europa.eu/european-union/index_en
Health Canada – Device https://www.google.com/webhp?sourceid=chrome-instant&rlz=1C1CHBF_enUS721US721&ion=1&espv=2&ie=UTF-8#q=health+canada+medical+device
National Health Service – UK – https://www.gov.uk/government/topics/national-health-service
Anvisa – Brazil – http://portal.anvisa.gov.br/
MHLW – Japan http://www.mhlw.go.jp/english/
Health Canada – Medical Device Authorizations related to COVID
Medical devices for expanded COVID-19 use: Authorized medical devices – Canada.ca
China Office- FDA
https://www.fda.gov/about-fda/office-global-operations/china-office
China – Approval of medical devices
https://www.gebiao-medical.com/china-medical-device-registration/
China – National Medical Products Administration
Standards
International Standards Organization (ISO) – http://www.iso.org/iso/home.html