FDA grants Accelerated Approval to Leqembi for treatment of Alzheimer’s disease

January 2023

The FDA has approved Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease. This approval came via the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and the drug is shown to have an effect on a surrogate endpoint that is likely to predict a clinical benefit to patients. For more information, see the FDA's press release.

FDA Clinical Investigator Training Course (CITC) 2022

December 2022

The FDA's recent Clinical Investigator Training Course (CITC) is now available online in video format. This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions, and to familiarize participants with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products. The course is targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators. For more information, see the FDA's event information page which includes an agenda (with links to the video material), brief overview, and links to relevant FDA resources.

FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age

December 2022

The FDA has amended the emergency use authorizations (EUAs) for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. These bivalent COVID-19 vaccines include an mRNA component corresponding to the original strain to provide an immune response that is broadly protective against COVID-19, as well as an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. For more information, see the FDA's press release.

FDA issues EUA for new Novavax COVID-19 vaccine, adjuvanted

July 2022

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

July 2022

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

June 2022

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 guidance: ICH E8(R1) General Considerations for Clinical Studies

April 2022

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.

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.

Novotech Drug Development Consulting 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 info@cbrintl.com.

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).

For more information about the eCTD v4.0, see the FDA's draft Technical Conformance Guide and Module 1 Implementation Package (here) and the current ICH implementation package (here).

Novotech Drug Development Consulting (formerly CBR International) has 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.