New Product Development

New Product Development / en Sun, 27 Apr 2025 21:25:03 -0500 Mon, 25 Oct 21 13:33:36 -0500 NIH, FDA act to increase access to over-the-counter COVID-19 tests /news/headline/2021-10-25-nih-fda-act-increase-access-over-counter-covid-19-tests The National Institutes of Health will use $70 million from the American Rescue Plan Act for a program to speed development of accurate and reliable over-the-counter tests for COVID-19, the Department of Health and Human Services <a href="https://www.hhs.gov/about/news/2021/10/25/new-hhs-actions-add-biden-administration-efforts-increase-access-easy-use-over-counter-covid-19-tests.html">announced</a>&nbsp;today. The NIH Independent Test Assessment Program will work with the Food and Drug Administration, manufacturers and experts to speed emergency use authorizations for new tests that can increase production quickly, officials said. In related news, FDA recommended labeling <a href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas">updates</a>&nbsp;to facilitate over-the-counter single-use testing for symptomatic individuals for tests currently authorized only for serial testing. It also granted an <a href="https://www.fda.gov/media/153418/download">emergency use authorization</a>&nbsp;to Celltrion Diatrust for an over-the-counter rapid antigen test, and <a href="https://www.fda.gov/media/147247/download">reauthorized</a>&nbsp;the Quidel QuickVue at-home test to add over-the-counter single-use testing for symptomatic adults and children. &nbsp; Mon, 25 Oct 2021 13:33:36 -0500 New Product Development FDA greenlights injection to aid tracheal intubation /news/headline/2020-09-08-fda-greenlights-injection-aid-tracheal-intubation The Food and Drug Administration last week approved a new drug for facilitating tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. FDA said that approving <a href="https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&amp;Appl_No=213527#152">cisatracurium besylate USP 20 mg/10mL injections</a> via an abbreviated new drug application addresses a shortage for a medical product that is in increased demand. The agency noted the drug’s side effects include bradycardia, hypotension, flushing, bronchospasm and rash. Tue, 08 Sep 2020 14:39:20 -0500 New Product Development FDA approves new tracheal intubation drug /news/headline/2020-06-10-fda-approves-new-tracheal-intubation-drug The Food and Drug Administration Monday approved a new <a href="https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&amp;Appl_No=213432#19">injection</a>&nbsp;to assist in tracheal intubation and provide muscle relaxation during surgeries or mechanical ventilation. FDA said side effects include anaphylaxis, hyperkalemia and malignant hyperthermia. Wed, 10 Jun 2020 14:44:57 -0500 New Product Development