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January 12 & 26 - FDA virtual Town Hall series on COVID-19 test development and validation

Updated - January 2022

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:
January 12, 2022; 12:15-1:15 PM, US Eastern Time
January 26, 2022; 12:15-1:15 PM, US Eastern Time
February 9, 2022; 12:15-1:15 PM, US Eastern Time
February 23, 2022; 12:15-1:15 PM, US Eastern Time

FDA authorizes first oral antiviral treatment for COVID-19

December 2021

The FDA has issued an emergency use authorization (EUA) for Paxlovid (nirmatrelvir tablets and ritonavir) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older). This is the first oral antiviral that has been authorized for COVID-19 treatment. For more information, read the FDA press release.

FDA updates fact sheet on Janssen COVID-19 vaccine

December 2021

The FDA has updated its fact sheet on the Janssen COVID-19 vaccine to address safety concerns about thrombosis. For more information, read the FDA fact sheet.

FDA updates guidance on EUA for COVID-19 diagnostic tests

November 2021

The FDA has updated its guidance regarding emergency use authorization (EUA) for COVID-19 diagnostic tests. Companies are now required to submit an EUA request for use of these tests. For more information, see the final guidance document. For a summary of this and other recent related policy changes, see the FDA press release.

FDA clears first 510(k) for a COVID-19 test, issues EUA for new OTC test

November 2021

The FDA has cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2 from BioFire Defense, LLC. This test has been offered under EUA since March 2020; this new marketing authorization permits the test to be marketed beyond the COVID-19 public health emergency. For more information, see the FDA's 510(k) Premarket Notification.

The FDA has also issued an emergency use authorization (EUA) for a new over-the-counter COVID-19 test, the iHealth COVID-19 Antigen Rapid Test. For more information, see the FDA's authorization letter.

FDA advisory committee recommends EUA for COVID-19 vaccine in children aged 5-11

October 2021

An FDA advisory committee voted to recommend emergency use authorization (EUA) for a smaller dose of the Pfizer-BioNTech COVID-19 vaccine in children of ages 5 to 11. The FDA is expected to make a final ruling in the coming days. For more information, read this New York Times article or see the full meeting materials.

FDA amends EUA to expand use of booster dose for COVID-19 vaccines

October 2021

The FDA is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose in certain eligible populations. The guidance covers the Moderna vaccine, the Janssen (Johnson and Johnson) vaccine, and "mix and match" booster doses of the available vaccines. It also clarifies the use of booster doses of the Pfizer-BioNTech vaccine. For more information, read the FDA press release.

FDA to withdraw temporary guidances/policies for manufacturers of hand sanitizer

October 2021

Effective December 31, 2021, the FDA will withdraw temporary guidances/policies, originally issued in March 2020, allowing non-drug manufacturers to produce certain alcohol-based hand sanitizers during the public health emergency. For more information, read the FDA press release.

UPDATED - September 17 - FDA Advisory Committee Meeting on Pfizer-BioNTech COVID-19 vaccine booster

Updated - September 2021

On August 23 the FDA approved the first COVID-19 vaccine, from Pfizer-BioNTech, to be marketed as Comirnaty. This vaccine is approved for the prevention of COVID-19 in individuals 16 years of age and older. The vaccine also continues to be available under EUA, for individuals 12 through 15 years of age, and for a third dose in certain immunocompromised individuals. For more information about this approval and about the vaccine, read the FDA press release.

On September 17, 2021, the FDA will hold an Advisory Committee Meeting to discuss Pfizer-BioNTech's supplemental application for administration of a third ("booster") dose of the Comirnaty vaccine. For more information, read the FDA press release.

FDA implementing new Study Data Standards for submissions to CDER and CBER

August 2021

On September 15, 2021, the FDA will implement new Study Data Standards for submissions to CDER and CBER. The new standards apply to clinical and nonclinical studies started after December 17, 2016 (for NDAs, BLAs, and ANDAs) or December 17, 2017 (for commercial INDs). Files must comply with CDISC standards as specified in the guidance document "Providing Regulatory Submissions in Electronic Format — Standardized Study Data". Study data validation will apply to only certain eCTD sections, while other sections will be exempt. For more information, read FDA's information page or see the Technical Rejection Criteria for Study Data (PDF).

FDA approves the first interchangeable biosimilar insulin product

June 2021

The FDA has approved Semglee (insulin glargine-yfgn) to improve glycemic control in patients with Type 1 or Type 2 diabetes mellitus. This is the first interchangeable biosimilar product that has been approved in the US for the treatment of diabetes. This and any subsequent such approvals can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. For more information, read the FDA press release or see product information (PDF).

New FDA fact sheets on biosimilars

July 2021

The FDA has released several new fact sheets on biosimilars for health care providers, to improve understanding about biosimilar and interchangeable biosimilar products:
- Overview of Biosimilar Products (PDF)
- Biosimilar Regulatory Review and Approval (PDF)
- Interchangeable Biological Products (PDF)

FDA approves Aduhelm (aducanumab) for treatment of Alzheimer’s disease

June 2021

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

May 2021

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

April 2021

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

June 2020

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)

April 2020

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 info@cbrintl.com.

FDA Guidances: Providing Regulatory Submissions in eCTD and Alternate Electronic Formats

March 2020

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).

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).

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.

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CBR will maintain business continuity during the COVID-19 outbreak

March 2020

CBR has designed its systems to ensure employees can securely provide continued service to clients while onsite from our offices, or via telecommuting due to a short-term or extended office closure. Should our offices be closed due to potential exposure to COVID-19, we will continue to operate and provide ongoing support to clients. Read our official statement here [PDF].

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