For immediate release:

The United States Food and Drug Administration today announced the following actions taken as part of its ongoing response efforts to the COVID-19 pandemic:

  • Today, the FDA released a statement titled “FDA to Follow Science on COVID-19 Vaccines for Young Children” attributed to Acting FDA Commissioner Janet Woodcock, MD and Peter Marks, MD, Ph. D., director of the Center for Biologics Research at the FDA. and evaluation.
  • On September 3, the FDA approved an Abbreviated New Drug Application for Dexmedetomidine Injection USP, 200 mcg / 2 ml, indicated for the sedation of initially intubated and mechanically ventilated patients during intensive care treatment and patient sedation. not intubated before and / or during surgical and other procedures. The most common side effects of injecting dexmedetomidine hydrochloride are hypotension (low blood pressure), bradycardia (slow heartbeat), and dry mouth. This drug is listed in the FDA Drug Shortage Database.

    FDA recognizes increased demand for certain products during COVID-19 public health emergency and has prioritized reviewing generic drug applications for potential treatments and supportive therapies for patients with COVID-19 . We remain deeply committed to facilitating access to safe and effective medical products to help meet the critical needs of the American public.

  • On September 8, the agency cleared the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine for use of an additional batch of vaccine drug substance manufactured in the Emergent installation. To date, a total of six batches of the Janssen drug substance that have been manufactured at the Emergent facility have been authorized. The FDA has conducted a thorough review of the facility records and the results of the manufacturer’s quality tests. Based on this review and given the current public health emergency related to COVID-19, the FDA has concluded that these lots can be used. Although the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to resolve issues with the management of Janssen and Emerging BioSolutions.
  • On September 9, the FDA revised the Development of Abbreviated New Drug Applications during the COVID-19 Pandemic – Questions and Answers guide, originally released in April 2021. The guide provides general recommendations to potential generic drug applicants regarding drug development generic and regulatory question-and-answer submissions that were received and processed by the FDA during the COVID-19 public health emergency.

    The FDA issued these guidelines so that generic drug development and submissions can continue during the COVID-19 public health emergency, helping to ensure that Americans continue to have access to safe and secure generic drugs. effective.

  • Testing updates:
    • To date, 409 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUA). These include 287 molecular tests and specimen collection devices, 88 antibody tests and other immune response tests, and 34 antigen tests. There are 62 molecular clearances and one antibody clearance that can be used with home samples. There is one at-home molecular prescription test, three at-home antigen prescription tests, seven at-home over-the-counter (OTC) antigen tests, and two at-home over-the-counter molecular tests.
    • The FDA has authorized 14 antigen tests and eight molecular tests for serial screening programs. The FDA has also cleared 632 reviews of EUA authorizations

Related information

###

Boilermaking

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.