TRP_1170x120_12-19-19

FDA

FDA approves new therapy for Dravet syndrome

FDA approves new therapy for Dravet syndrome

SILVER SPRING, Md. — The U.S. Food and Drug Administration  approved on Friday Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite

FDA completes review investigational new drug application from BioSig

FDA completes review investigational new drug application from BioSig

WESTPORT, Conn.— BioSig Technologies announced that the U.S. Food and Drug Administration (FDA) has completed its review of ViralClear’s Investigational New Drug (IND) application. The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or

FDA Issues emergency use authorization for remdesivir for treatment of COVD-19

FDA Issues emergency use authorization for remdesivir for treatment of COVD-19

WASHINGTON — On Friday, the U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the

NIH and FDA announcements confirm Agilum’s April 7th Real-World Evidence (RWE) of COVID-19 drug treatment observations

NIH and FDA announcements confirm Agilum’s April 7th Real-World Evidence (RWE) of COVID-19 drug treatment observations

DEERFIELD BEACH, Fla. —  The National Institutes of Health (NIH) released a statement this week warning against the use of hydroxychloroquine (HCQ) in combination with azithromycin. This conclusion mirrors Agilum Healthcare Intelligence’s real-world evidence published two weeks earlier on April 7th. Agilum was also pleased that the U.S. Food and Drug Administration (FDA) issued a

FDA authorizes first test for at-home sample collection for COVID-19

FDA authorizes first test for at-home sample collection for COVID-19

WASHINGTON — The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test

Supplement industry associations applaud FDA actions to protect consumers from fraudulent products related to COVID-19

Supplement industry associations applaud FDA actions to protect consumers from fraudulent products related to COVID-19

WASHINGTON — The U.S. dietary supplement industry commends the Food and Drug Administration (FDA) for taking action to protect consumers by calling out marketers who make illegal and unsubstantiated drug claims related to COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2.   In February, the industry issued strong warning to companies and consumers to avoid

FDA issues first Emergency Use Authorization for point-of-care diagnostic

FDA issues first Emergency Use Authorization for point-of-care diagnostic

WASHINGTON — The U.S. Food and Drug Administration issued the first Emergency Use Authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out

FDA issues guidance for conducting clinical trials during COVD-19 pandemic

FDA issues guidance for conducting clinical trials during COVD-19 pandemic

WASHINGTON — The U.S. Food and Drug Administration Wednesday has issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products. Challenges may arise, for example,

FDA rolls out new campaign to help consumers read the label

FDA rolls out new campaign to help consumers read the label

SILVER SPRING, Md. —  The U.S. Food and Drug Administration has launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices. The campaign with the tagline “What’s In It For You?” aims to reach the general public and also focuses on consumers at

Leaders from 24 companies in pharma supply chain working on MediLedger DSCSA Pilot Project

Leaders from 24 companies in pharma supply chain working on MediLedger DSCSA Pilot Project

SAN FRANCISCO — At the beginning of 2019, the U.S. Food and Drug Administration (FDA) began accepting pilot project proposals to identify solutions for meeting the 2023 requirements of the Drug Supply Chain and Security Act (DSCSA). The U.S. Congress passed the DSCSA to improve the security of the pharmaceutical supply chain to help eliminate

Dr. Stephen Hahn confirmed as FDA Commissioner

Dr. Stephen Hahn confirmed as FDA Commissioner

WASHINGTON — The United States Senate voted, 72-18, on Thursday to confirm Dr. Stephen Hahn as Commissioner of Food and Drugs. Health and Human Services Secretary Alex Azar issued the following statement: “I congratulate Dr. Hahn and thank the Senate for prioritizing his nomination. President Trump has chosen a superbly qualified leader for FDA, and

CHPA petitions FDA to establish a clear path for CBD in dietary supplements

CHPA petitions FDA to establish a clear path for CBD in dietary supplements

WASHINGTON — The Consumer Healthcare Products Association (CHPA) submitted on Thursday a citizen petition to the U.S. Food and Drug Administration (FDA) urging the agency to exercise its existing statutory authority to swiftly issue regulations that establish a clear pathway for manufacturers to lawfully market cannabidiol (CBD) in dietary supplements. “Intense consumer demand and commercial interest

Scott Gottlieb to keynote PLMA opening breakfast

Scott Gottlieb to keynote PLMA opening breakfast

ROSEMONT, Ill. —  Dr. Scott Gottlieb, who served as commissioner of the Food and Drug Administration from 2017-2019, will deliver the keynote for the opening breakfast at the Private Label Manufacturers Association’s 2019 Private Label Trade Show at the Rosemont Convention Center on Monday, November 18. Gottlieb, who drew plaudits from Democrats and Republicans alike for his

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