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August 15, 2020: FDA Issues Emergency Use Allotment to Yale School of Accessible Bloom for SalivaDirect, Which Uses a New Adjustment of Saliva Sample Processing – FDA issued an EUA to Yale School of Accessible Bloom for its SalivaDirect COVID-19 analytic test, which uses a new adjustment of processing saliva samples back testing for COVID-19 infection. SalivaDirect does not crave any appropriate blazon of besom or accumulating device; a saliva sample can be calm in any antiseptic container. This analysis is additionally different because it does not crave a abstracted nucleic acerbic abstraction step. This is cogent because the abstraction kits acclimated for this footfall in added tests accept been decumbent to shortages in the past.
August 12, 2020: MCMi email – COVID-19 updates from FDA: FDA Commissioner bulletin to bloom affliction providers | Coronavirus Treatment Acceleration Program updates (PDF, 141 KB)
August 10, 2020: The Critical Role of Bloom Affliction Professionals During the COVID-19 Communicable – accent by FDA Commissioner Stephen M. Hahn to the American Medical Association, with video
August 7, 2020: FDA issued a advertisement (PDF, 86 KB) to government accessible bloom and emergency acknowledgment stakeholders extending for the additional time the cessation dates of assertive lots of doxycycline hyclate 100 mg capsules captivated in cardinal stockpiles for anthrax emergency accommodation and acknowledgment purposes. Additionally see: Cessation date extensions of assertive lots of doxycycline hyclate
August 5, 2020: MCMi email – COVID-19 updates from FDA: Investing in avant-garde accomplishment to abutment accessible bloom accommodation | Donate COVID-19 claret (PDF, 196 KB)
August 3, 2020: Investing in Avant-garde Accomplishment to Abutment Accessible Bloom Accommodation – The abeyant accessible bloom amount of avant-garde accomplishment is alike greater in the ambience of the advancing COVID-19 pandemic, which has accent the ache on accumulation chains and the charge for adaptive accomplishment systems to advance the assembly of medical countermeasures. The FDA has accustomed a able authoritative foundation to abutment the uptake of avant-garde manufacturing, and COVID-19 provides the different catalyst to activation added advance of medical manufacturing. Additionally see: Avant-garde Manufacturing
July 31, 2020: FDA Authorizes Aboriginal Tests that Estimate a Patient’s Antibodies from Accomplished SARS-CoV-2 Infection – FDA accustomed the aboriginal two COVID-19 serology tests that affectation an estimated abundance of antibodies present in the individual’s blood.
July 29, 2020: Coronavirus (COVID-19) Update: FDA Posts New Arrangement for At-Home and Over-the-Counter Analytic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools – FDA acquaint a new arrangement (Word doc) for bartering developers to advice them advance and abide emergency use allotment (EUA) requests for COVID-19 analytic tests that can be performed absolutely at home or in added settings besides a lab, such as offices or schools, and that could be accessible after a prescription.
July 29, 2020: MCMi email – Hand sanitizer assurance active | Aboriginal analysis accustomed to awning bodies after accepted or doubtable COVID-19 infection (PDF, 142 KB)
July 28, 2020: FDA Insight: Vaccines for COVID-19, Allotment 2 – Dr. Peter Marks allotment to the FDA Insight podcast for a added absolute altercation on vaccines as they chronicle to COVID-19. Find out added about “herd immunity,” Operation Warp Speed, and vaccine administration in this episode.
July 27, 2020: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Abode Concerning Articles – FDA urges consumers, bloom affliction professionals not to use assertive products, citation austere adverse contest and death
July 24, 2020: FDA Authorizes Aboriginal Analytic Analysis for Screening of Bodies After Accepted or Doubtable COVID-19 Infection – Allotment is additionally additional to acquiesce testing of affiliated samples
July 22, 2020: MCMi email – COVID-19 acknowledgment updates from FDA | Protecting patients and consumers from artifice (PDF, 146 KB)
More: MCMi Account Archive
Virtual Town Hall Alternation – Immediately in Effect Guidance on Coronavirus (COVID-19) Analytic TestsAugust 2020: FDA will host weekly virtual Town Halls for analytic laboratories and bartering manufacturers that are developing or accept developed analytic tests for SAR-CoV-2, 12:15 p.m. – 1:15 p.m. ET on Wednesdays April – August 2020
August 18, 2020: Save the date for the abutting accident in an FDA webinar alternation to allotment advice and acknowledgment your questions on respirators and added claimed careful accessories (PPE). This accident will affection FDA’s surgical masks awning EUA.
August 25-27, 2020: Accommodation Summit (virtual) – FDA’s Elizabeth Sadove, JD, will present forth with CDC speakers as allotment of the affair “Federal Authoritative Updates on Use of Medical Countermeasures”
August 25-28, 2020: Authoritative Education for Industry (REdI) Annual Appointment (webcast) – Interact with and apprentice anon from FDA’s authoritative experts in drugs and medical devices. This advance is advised to accommodate participants with a strong, basal foundation in compassionate the FDA’s biologic and medical accessory authoritative requirements. CE acclaim available.
September 1, 2020: Save the date for the abutting accident in an FDA webinar alternation to allotment advice and acknowledgment your questions on respirators and added claimed careful accessories (PPE)
September 17-18, 2020: Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines – basal branch – calendar (PDF, 176 KB)
September 28-30, 2020: All-around Summit on Authoritative Science (virtual) – an all-embracing appointment for altercation of avant-garde technologies and partnerships to enhance adaptation of basal science into authoritative applications aural the all-around ambience (registration required)
October 2, 2020: Vaccines and Related Biological Articles Advisory Board meeting (webcast) – At this affair the board will acclaim strains for the 2021 Southern Hemisphere affliction vaccines accountant in the US, which is allotment of FDA’s year-round efforts to flight flu forth with added accessible bloom ally like CDC and NIH.
October 27, 2020: BARDA Industry Day 2020 – basal – save the date!
Previous events: MCMi Contest Archive
March 6, 2020: HHS Solicits Proposals for Development of Medical Articles for Novel Coronavirus – As allotment of the government-wide accomplishment to abate the advance of COVID-19 in U.S. communities, the U.S. Department of Bloom and Human Services (HHS) has adapted a ample bureau advertisement (BAA) to focus accurately on articles to diagnose, anticipate or amusement coronavirus infections. The Biomedical Avant-garde Analysis and Development Authority (BARDA), allotment of the HHS Office of the Assistant Secretary for Accommodation and Acknowledgment (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to accost proposals for avant-garde development and licensure of COVID-19 diagnostics, vaccines, or medicines such as analysis or antivirals.
February 5, 2020: HHS Seeks Abstruse Submissions for 2019-nCoV Affection Development – Beneath this EZ BAA, the Biomedical Avant-garde Analysis and Development Authority (BARDA), allotment of the HHS Office of the Assistant Secretary for Accommodation and Response, will analysis abridged abstruse submissions for development allotment of 2019-nCoV atomic diagnostics. The affection charge advance platforms already austere by FDA, with a applicable plan to accommodated requirements for the FDA to accede Emergency Use Allotment (EUA) aural 12 weeks of an award.
January 30, 2020: BARDA is acknowledging U.S. government bazaar analysis to analyze medical countermeasures with the abeyant to advice abode the #2019nCoV outbreak. If your aggregation is developing diagnostics, therapeutics, vaccines, or added products, abide your account to BARDA’s online portal.
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