May 13, May 20, May 27 - FDA virtual Town Halls for labs and manufacturers on COVID-19 diagnostic tests
On May 13, May 20, and May 27, 2020, the FDA will host virtual Town Hall meetings
for clinical laboratories and commercial manufacturers that are developing or have
developed diagnostic tests for COVID-19 (SARS-CoV-2). 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.
Dates and Times:
Wednesday, May 13, 2020; 12:15-1:15 PM, US Eastern Time
Wednesday, May 20, 2020; 12:15-1:15 PM, US Eastern Time
Wednesday, May 27, 2020; 12:15-1:15 PM, US Eastern Time
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 email@example.com.
UPDATED - FDA Guidance: Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On March 18, 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 or read the press release.
The guidance was amended on March 27 to include an appendix that provides further explanation, with answers to relevant questions that the FDA has received during the pandemic.
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.