Tag: FDA

25
Jun

FDA Cleared First Video Game to Treat Children with ADHD

Endeavor: Digital Therapeutic (the First Prescription Non-Drug Treatment) to Improve Attention in Children with ADHD Delivered Through an Action Video Game The US Food and Drug Administration (FDA) cleared the first digital prescription attention treatment device (EndeavorRx™: prescription-only game-based device) to improve attention in pediatric patients ages 8 to 12 years old  with attention deficit hyperactivity disorder (ADHD) delivered through

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23
Jun

Nine Toxic Hand Sanitizers by FDA

Nine Brands of Toxic Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol)  The US Food and Drug Administration determined that samples of hand sanitizers, Lavar Gel and CleanCare NoGerm, contain methanol (wood alcohol), a toxic substance when absorbed through the skin or ingested. Methanol should not be used as an ingredient in hand sanitizers due to its toxic

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17
Jun

Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency

Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency FDA has issued a Guidance for Industry entitled “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.” This guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency. 

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12
Apr

FDA Approved First Biosimilar Zarxio filgrastim-sndz

The First FDA-Approved Biosimilar Zarxio filgrastim-sndz March 6, 2015 The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based

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6
Apr

FDA Approved an IND for Zika Virus

U.S. Food and Drug Administration An IND Approved for Zika Virus The US FDA recently approved an investigational new drug application (IND)* for a test to screen blood donations for Zika virus.  The test is manufactured by Roche Molecular Systems, Inc. (Roche). *: The IND regulations 21 CFR Part 312 (downloadable in PDF here) provides procedures and requirements governing the use of

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23
Mar

US Congressman Sent a Letter to Veterans Affairs Not to Allow Essure

Hon. Mike Fitzpatrick Sent a Letter to the Veterans Affairs and Related Agencies Not to Purchase Medical Device Essure March 1, 2016 The Honorable Charlie Dent Chairman Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC-227 The Capitol Washington, DC 20515 The Honorable Sanford Bishop, Jr. Ranking Member Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC- 227

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19
Mar

US FDA and Health Canada Audit Program Status for ISO 13485

The United States Food and Drug Administration (FDA) The Center for Devices and Radiological Health (CDRH) Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program The FDA/CDRH is terminating Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program. FDA will no longer accept ISO 13485:2003 voluntary audit reports with an audit end date of April 1, 2016

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13
Jan

FDA UDI Final Rule

Food and Drug Administration The Unique Device Identification (UDI) Final Rule On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule).  The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies. The rule will be

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16
Dec

First of Kind Military Wound Dressing Cleared for Civilian Use

Food and Drug Administration (FDA) Clearance for Traumatic Wound Dressing XSTAT 30 Wound Dressing FDA clears military traumatic wound dressing for use in the civilian population FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin

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3
Dec

Apply for FDA Patient Representative Program

United States Food and Drug Administration (FDA) About the Patient Representative Program The FDA is committed to making more opportunities for patients to participate in FDA decision-making. The FDA recruits Patient Representatives on an as-needed basis to: Help advise us on drugs, devices, and biologics that are currently being considered for approval Give us input earlier in the regulatory medical product

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