The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA posted a statement titled “FDA Will Follow The Science On COVID-19 Vaccines For Young Children” attributed to Acting FDA Commissioner Janet Woodcock M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation.
- On September 3, the FDA approved an abbreviated new drug application for dexmedetomidine injection USP, 200 mcg/2 mL, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth. This drug is listed in the FDA Drug Shortage Database.
The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and has prioritized the review of 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 address critical needs of the American public.
- On September 8, the agency authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of one additional batch of vaccine drug substance manufactured at the Emergent facility. To date, a total of six batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While 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 work through issues there with Janssen and Emergent BioSolutions management.
- On September 9, the FDA revised the guidance Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, originally published in April 2021. The guidance provides general recommendations to prospective generic drug applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency.
The FDA issued this guidance so that the development of generic drugs and submission of applications can continue during the COVID-19 public health emergency, ultimately helping ensure Americans continue to have access to safe and effective generic drugs.
- Testing updates:
- As of today, 409 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 287 molecular tests and sample collection devices, 88 antibody and other immune response tests and 34 antigen tests. There are 62 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, seven antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 14 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 632 revisions to EUA authorizations
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Coronavirus (COVID-19) Update: September 10, 2021