June 2, 9, 16, 23, & 30 - FDA virtual Town Hall series on COVID-19 test development and validation
Updated - June 2021
The FDA continues its series of virtual Town Hall meetings
for developers of COVID-19 (SARS-CoV-2) diagnostic tests.
The FDA will answer technical questions about the development
and validation of these tests. For more information,
see FDA's information page for these meetings.
Upcoming Dates and Times:
June 2, 2021; 12:15-1:15 PM, US Eastern Time
June 9, 2021; 12:15-1:15 PM, US Eastern Time
June 16, 2021; 12:15-1:15 PM, US Eastern Time
June 23, 2021; 12:15-1:15 PM, US Eastern Time
June 30, 2021; 12:15-1:15 PM, US Eastern Time
FDA approves Aduhelm (aducanumab) for treatment of Alzheimer’s disease
The FDA has approved Aduhelm (aducanumab) for the treatment of Alzheimer's disease. It is the first therapy to target the fundamental pathophysiology of the disease. Aduhelm was granted Fast Track designation and was approved under the Accelerated Approval Program, allowing patients earlier access to treatment. Under the provisions of the approval, the FDA is requiring the drug maker to conduct a new clinical trial to verify the drug's clinical benefit. For more information, read the FDA press release or see product information. Additionally, FDA CDER Director Patrizia Cavazzoni wrote a perspective on FDA's approval decision.
UPDATED - FDA Guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19
Updated - May 2021
In October 2020, the FDA issued a new guidance for industry to assist sponsors of Emergency Use Authorization (EUA) requests for COVID-19 vaccines. This guidance provides recommendations about the data and information needed to support the issuance of an EUA for an investigational COVID-19 vaccine for the duration of the COVID-19 public health emergency. For more information, see the guidance document.
The guidance was updated on February 22 and again on May 25. The February update included the FDA’s scientific recommendations for modifications to authorized vaccines, as well as recommendations for safety assessments to support an EUA for a modified vaccine. The most recent update added a new section that clarifies how the FDA will prioritize review of EUA requests for the remaining duration of the COVID-19 public health emergency.
New FDA Guidances Related to COVID-19: Regulatory and Policy FAQ; Master Protocols
The FDA has issued these noteworthy new guidances for industry related to the ongoing COVID-19 public health emergency:
"Manufacturing, Supply Chain, and Drug and Biological Product Inspections - Questions and Answers" - This guidance provides answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products during the COVID-19 public health emergency. For more information, see the guidance document.
"Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention of COVID-19" - This guidance provides recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19. For more information, see the guidance document.
New FDA Guidances Related to COVID-19: Remote Interactive Evaluations; ANDAs; Container Closure Systems
The FDA has issued several new guidances for industry related to the ongoing COVID-19 public health emergency:
"Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities" - This guidance describes how FDA will request and conduct voluntary remote interactive evaluations of facilities for the duration of the COVID-19 public health emergency. For more information, see the guidance document.
"Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers" - This guidance provides general recommendations to applicants and prospective applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA. For more information, see the guidance document.
"COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers" - This guidance collates recommendations for appropriate reporting category and the content of postapproval change submissions across numerous FDA guidance documents. It provides recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved parenteral drug and biological products. The guidance also discusses pathways available to application holders to obtain FDA feedback, and discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. For more information, see the guidance document.
UPDATED - FDA Guidance: Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
Updated - July 2020
In March 2020, the FDA issued a new guidance for industry, investigators, and institutional review boards on conducting clinical trials during the coronavirus (COVID-19) pandemic. The guidance includes considerations for assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the pandemic. For more information, see the guidance document.
The guidance was updated on July 2. It now includes updated information regarding the collection of informed consent from a prospective trial participant, and provides recommendations regarding video conferencing for trial visits.
FDA Guidance: Development and Licensure of Vaccines to Prevent COVID-19
The FDA has issued a new guidance for industry to assist sponsors in the development and licensure of vaccines for the prevention of COVID-19 (SARS-CoV-2). This guidance provides recommendations regarding the required data for manufacturing, clinical development, and approval of a COVID-19 vaccine. It also provides an overview of key considerations and statistics to determine vaccine safety and efficacy. For more information, see the guidance document.
FDA's Coronavirus Treatment Acceleration Program (CTAP)
FDA has created a new emergency program, called 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 currently assisting clients with COVID-19 development programs and we are very familiar with the Coronavirus Treatment Acceleration Program (CTAP). We are assisting clients through this process to accelerate 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 has 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.
FDA's new Purple Book database
The FDA has launched its new online Purple Book to help patients and prescribers identify FDA-approved biologic and biosimilar treatment options. The new format is a searchable database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products. The database, and more information about it, can be found here: Purple Book.
FDA CDER releases New Drug Therapy Approvals 2019 Report
The FDA’s Center for Drug Evaluation and Research (CDER) has released their annual "New Drug Therapy Approvals" report, covering notable new drug approvals and illustrating CDER’s role in bringing innovative, safe, and effective drug therapies to patients in need. The report includes new drug products, new uses of existing drugs, and new biosimilar approvals. CDER director Janet Woodcock offered her perspective on some of the the trends and achievements covered in the report; read it here. The report itself can be found here: New Drug Therapy Approvals 2019.
Stephen Hahn confirmed as FDA commissioner
Stephen Hahn has been confirmed as the next FDA commissioner. Read CNN's report here.
FDA approves Calquence (acalabrutinib) for treatment of chronic lymphocytic leukemia
As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, the FDA approved Calquence (acalabrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). For more information, read the FDA press release or see product information [PDF]. This is the second collaborative international approval granted under Project Orbis. Learn more about Project Orbis here.
FDA approves Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab)
The FDA has approved Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab), marking the 25th biosimilar approval in FDA’s effort to foster competition in the biologics market. For more information, read the FDA press release or see product information [PDF].
FDA News: reorganization of several CDER offices
The FDA’s Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products has been reorganized and renamed the Office of Oncologic Diseases. Learn more here.
CDER also plans to restructure the Office of New Drugs, with corresponding changes in the Office of Translational Sciences and Office of Pharmaceutical Quality. For more information, including implementation plans and timelines, read FDA's announcement.