FDA issues EUA for new Novavax COVID-19 vaccine, adjuvanted
The FDA has issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 in individuals 18 years of age and older. The vaccine is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant; the adjuvant is incorporated to enhance the immune response of vaccinated individuals. For more information, see the FDA's press release or the vaccine information page.
FDA revises Paxlovid EUA to allow prescribing by pharmacists in certain COVID-19 patients
The FDA has revised the emergency use authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations. Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years and older) who receive a positive COVID test result (direct SARS-CoV-2 viral test) and who are at high risk for progression to severe COVID-19. For more information, see the FDA press release.
FDA advisory committee recommends inclusion of omicron component for COVID-19 vaccine booster doses
The FDA's Vaccines and Related Biological Products Advisory Committee has recommended that COVID-19 vaccine manufacturers should develop modified vaccines that include a SARS-CoV-2 omicron BA.4/5 component, to be used for booster doses in the US beginning in fall 2022. For more information, see the FDA press release.
FDA amends EUAs for Moderna and Pfizer-BioNTech COVID-19 vaccines, expands eligibility to 6-month-old children
The FDA has amended the emergency use authorizations (EUA) for both the Moderna and the Pfizer-BioNTech COVID-19 vaccines to allow use of the vaccine in individuals as young as 6 months of age. The Moderna EUA previously allowed use in adults 18 years of age and older; the Pfizer-BioNTech EUA previously allowed use in individuals 5 years of age and older. For more information, including brief summaries of effectiveness and safety, see the FDA press release.
June 6-10 - FDA Regulatory Education for Industry (REdI) Conference
The FDA will be holding its Regulatory Education for Industry (REdI) annual conference on June 6 - 10, 2022. The goal of this conference is to provide a strong foundation in FDA regulatory requirements for drugs, biologics, and devices, and to create awareness of FDA's current activities. CBR encourages our staff and colleagues to attend one or more of the many excellent sessions being offered.
The conference agenda is available here.
Attendance to this virtual conference is free. Sessions are grouped by regulatory center,
with experts from the Center for Drug Evaluation and Research (CDER), Center for Biologics
Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH).
For more information, see
FDA's meeting information page
or the conference website.
Meeting Dates and Times:
June 6 - 10, 2022; 8:30 AM - 4:50 PM, US Eastern Time
FDA amends EUA for Pfizer-BioNTech COVID-19 vaccine booster dose, expands eligibility to children aged 5 - 11
The FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose for individuals 5 to 11 years of age. The EUA previously included individuals 12 to 15 years of age. For more information, see the FDA press release.
FDA authorizes first OTC test that detects COVID-19, flu, and RSV
The FDA has authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for individuals with symptoms of respiratory viral infection consistent with COVID-19. This is the first non-prescription multi-analyte COVID-19 test authorized by FDA. The test can identify and differentiate multiple respiratory viruses at the same time: influenza A and B, respiratory syncytial virus (RSV), and SARS-CoV-2 (COVID-19). For more information, see the FDA press release.
FDA publishes consumer update explaining "FDA approval"
The FDA has published a consumer update that explains how the FDA regulates products and clarifies what it means for certain products to be "FDA approved". The full article is available here.
FDA permits marketing for new test to improve diagnosis of Alzheimer's disease
The FDA has permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 protein concentrations found in human cerebrospinal fluid, to help physicians determine whether a patient is likely to have amyloid plaques, which are a hallmark sign of Alzheimer's disease. The FDA reviewed the device through the De Novo premarket review pathway, which creates a new regulatory device classification. The device was also granted Breakthrough Device designation. For more information, see the FDA press release.
New FDA guidance: Providing Submissions in Electronic Format - Postmarketing Safety Reports
The FDA has issued a new guidance document which provides general information on the electronic submission of postmarketing safety reports. This is part of a series of guidance documents on making regulatory submissions in electronic format to FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). For more information, see the new guidance document.
FDA approves first COVID-19 treatment for young children
The FDA has expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older, weighing at least 3 kilograms, with positive results of direct SARS-CoV-2 viral testing, who are hospitalized or who have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19. This is the first approved COVID-19 treatment for children less than 12 years of age. Veklury was previously approved for certain adults and pediatric patients at least 12 years of age, with emergency use authorization (EUA) for use in younger children; with this new approval, that EUA has been revoked. For more information, see the FDA press release.
FDA guidance: ICH E8(R1) General Considerations for Clinical Studies
The FDA has issued a new final guidance which replaces the previous version
issued in 1997, ICH E8 General Considerations for Clinical Trials.
This guidance describes internationally accepted principles and practices in
the design and conduct of clinical studies.
Significant updates include the following:
- Addresses study quality to ensure the protection of study participants and the generation of reliable and meaningful results, while promoting study efficiency.
- Addresses a broad range of study designs and data sources.
- Provides updated cross-referencing to other relevant ICH guidances that inform the design, planning, and conduct of clinical research.
For more information, see the new guidance document.
Updated FDA guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19
The FDA has updated its guidance regarding emergency use authorization (EUA) for COVID-19 vaccines. The new version includes updated recommendations for clinical data to support effectiveness of a vaccine that has been modified to target a particular variant, as well as updated information on evaluation of immune responses after vaccine boosters. Additionally, FDA has removed the expectation for sponsors to continue collecting placebo-controlled data after issuance of an EUA, due to the availability of safe and effective COVID-19 vaccines. The revised guidance also provides the most up-to-date recommendations based on lessons learned during the pandemic and submissions by sponsors. For more information, see the updated guidance document.
FDA authorizes new monoclonal antibody treatment for COVID-19
The FDA has issued an emergency use authorization (EUA) for a new monoclonal antibody, bebtelovimab, for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older). This new treatment retains activity against the omicron variant. For more information, read the FDA press release.
FDA's Coronavirus Treatment Acceleration Program (CTAP)
In 2020, FDA created the Coronavirus Treatment Acceleration Program (CTAP) to expedite development of potential treatments for COVID-19. This program aims to bring new treatments to patients as quickly as possible, while also supporting research to further evaluate the safety and effectiveness of those treatments. For more information, see FDA's overview of the CTAP program or read the press release.
CBR International is experienced in assisting clients with COVID-19 development programs and we are very familiar with the Coronavirus Treatment Acceleration Program (CTAP). We assist clients through this process to accelerate coronavirus-related products to the clinic. Please contact us if you need assistance or general advice: call us at 720-746-1190 or email firstname.lastname@example.org.
FDA Guidances: Providing Regulatory Submissions in eCTD and Alternate Electronic Formats
In February 2020, the FDA finalized its guidance on providing regulatory submissions in eCTD format (see the guidance document here). The guidance also specifies which submission types are exempt from eCTD requirements or may qualify for a long-term waiver, such as Type III drug master files. For those submission types, FDA issued a draft guidance on providing submissions in alternate electronic format (March 2020, see the guidance document here).
CBR International and our partner TruSubmit have over 15 years of experience in electronic submissions to the FDA and other regulatory authorities around the globe. To learn more about our comprehensive electronic submissions services, visit our Services page or contact us.