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Food and Drug Administration and Compliance Issues
The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:
Today, the FDAposted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. The FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on the notification list pending review of their EUA request.
The FDA issued the guidance “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” to help foster the continued availability of medical devices during the COVID-19 public health emergency. As described in the guidance, the FDA does not intend to object to limited modifications to the design and manufacturing of devices approved through either a PMA or HDE without prior submission of a PMA or HDE supplement or 30-day notice for the duration of the public health emergency. The policy set forth in the guidance does not apply to design or manufacturing changes made for reasons other than addressing manufacturing limitations or supply chain issues resulting from the COVID-19 public health emergency or to any proposed changes described in a regulatory submission already received by FDA.
The FDA approved two abbreviated new drug applications:
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, is 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, bradycardia, and dry mouth. This drug is listed in the FDA Drug Shortage Database.
Succinylcholine chloride injection USP 200 mg/10 mL, is indicated in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.
The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
Due to the COVID-19 pandemic and its impacts, earlier this month the U.S. District Court for the Eastern District of Texas granted a joint motion in the case of R.J. Reynolds Tobacco Co. et al. v. U.S. Food and Drug Administration et al. to govern proceedings in that case and postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule by 120 days. The new effective date of the final rule is Oct. 16, 2021. The FDA intends to update its relevant guidances related to the rule’s effective date and the timing for submission of cigarette plans.
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 105 tests under EUAs, which include 92 molecular tests, 12 antibody tests, and 1 antigen test.