Midazolam, used for COVID-19 care, is running low | DEA urged to raise narcotics production limit | Pfizer gets warning letter for sterile injectables plant in India
April 3, 2020
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Drugs & Biologics
An updated list of medications in shortage was released by the FDA on Thursday, and the list now includes the sedation drug midazolam, which is used for patients who require mechanical ventilation. Five manufacturers noted that the shortage was due to a higher demand for the drug.
Full Story: Regulatory Focus (4/2) 
Physician and pharmacy advocates sent a letter to the the Drug Enforcement Administration urging the agency to increase production limits of injectable fentanyl, hydromorphone, morphine and other narcotics used for COVID-19 patients on ventilators to ensure hospitals have enough supplies during the pandemic. A senior DEA official said the agency is closely monitoring the situation and has been discussing measures it could implement to accelerate a quota increase if necessary, though the agency believes the current limit is high enough for companies to meet the surge in demand.
Full Story: Reuters (4/2) 
Pfizer has received a warning letter from the FDA for its sterile injectables plant in Visakhapatnam, India. The facility's quality system does not ensure the "safety, effectiveness and quality of the sterile drugs" being shipped to the US, the letter states.
Full Story: FiercePharma (4/2) 
Medical Devices
President Donald Trump issued a memorandum allowing HHS to use authority under the Defense Production Act to help Generic Electric, Medtronic and four other manufacturers to obtain supplies needed for ventilator production.
Full Story: The Hill (4/3) 
The FDA is advising that it has not issued an emergency use authorization to a company called Bodysphere for a COVID-19 test despite false statements from the company that were distributed in the media. The agency is also warning people to be cautious of false coronavirus tests, drugs and devices.
Full Story: The New York Times (tiered subscription model) (4/1) 
An FDA official said the agency will now permit imports of KN95 masks, described as the Chinese version of an N95 mask, due to the scarce supply of personal protective equipment in the US. The FDA said it's "ready and available to engage with importers to minimize disruptions during the importing process," but it noted importers may want to verify the authenticity of the masks.
Full Story: The Hill (4/2) 
The FDA has given emergency use authorization to Cellex's SARS-CoV-2 serology test, which can deliver results within 15 minutes.
Full Story: Regulatory Focus (4/2) 
European regulators have given CE mark approval to Genetic Signatures' SARS-CoV-2 test kit.
Full Story: 360Dx (tiered subscription model) (4/1) 
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