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FDA publishes temporary guidance on manufacturing, supply chain, product inspections during COVID-19
expresspharma
August 21, 2020
US FDA has announced the availability of temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.”
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FDA publishes revised MAPP, Consolidation of ANDAs by the Office of Generic Drugs
expresspharma
August 21, 2020
This MAPP describes the process for reviewing and approving or denying requests to consolidate previously approved ANDAs submitted by an applicant.
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US FDA declines approval for Gilead’s rheumatoid arthritis drug, Filgotinib
expresspharma
August 20, 2020
The US drug regulator has issued a complete response letter requesting data from the MANTA and MANTA-RAy studies and expressing concerns regarding the overall benefit/risk profile of the drug.
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FDA Issues EUA to Yale School of Public Health for SalivaDirect COVID-19 Test
americanpharmaceuticalreview
August 20, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection
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Dietary Supplement Clinical Trials
Lin Zhang
August 20, 2020
Dietary supplements are common support therapy and have been shown to improve energy, protein, micronutrients intake, maintain or improve nutritional status.
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US FDA publishes compliance policy for quantity of samples retained for BA and BE studies
expresspharma
August 20, 2020
The US FDA has published the guidance for industry entitled “Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c).”
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Kimera® Labs Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19
prnewswire
August 19, 2020
Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class ...
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Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Antibody Testing System
prnewswire
August 19, 2020
Accelerate Diagnostics, Inc. and BioCheck, Inc., a privately-held San Francisco-based company focused on in vitro diagnostics, announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the ...
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FDA accepts Enzychem’s IND for trial of Covid-19 treatment candidate
pharmaceutical-business-review
August 19, 2020
The US Food and Drug Administration (FDA) has accepted Enzychem Lifescience’s investigational new drug application (IND) to assess its EC-18 therapeutic candidate for the prevention of acute respiratory disease syndrome (ARDS) due to Covid-19 pneumonia.
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FDA Approves Initiation of IGC’s Cannabinoid Trial on Alzheimer’s Patients
americanpharmaceuticalreview
August 19, 2020
The U.S. Food and Drug Administration (FDA) notified India Globalization Capital (IGC) it has authorized the initiation Phase 1 human trial study for the Company’s investigational cannabinoid formulation for the treatment of patients suffering from ...