Vizient, Inc. today submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.
Hi-Tech Pharmaceuticals sued the FDA May 2nd, 2019 in Federal Court- Case 1:19-cv-01268, claiming the agency bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.
The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.
"The Optimal Solution" is a team of seasoned industry innovators cooperatively leveraging their expertise to demonstrate interoperability at scale in the pharma supply chain ecosystem. Team members include: RXTransparent, Systech, T-Systems, FarmaTrust, Cryptowerk and CalQLogic.
Food and Drug Administration Acting Commissioner Ned Sharpless announced a new FDA.org website to launch this week.
As part of a continuing effort to modernize and reform the oversight of dietary supplements, the Food and Drug Administration announced a public meeting on May 16 from 8:30 a.m. to 4 p.m. to canvass ideas on facilitating responsible innovation.
Corey Polen was a healthy 40-year-old man enjoying his life with his wife and three children. In October of 2015 that all changed when he started feeling spurts of weakness, not thinking too much about it until it began to progress rapidly with no answers.
The world of pharmaceuticals and biotechnology is ever-growing and changing, but seemingly only behind closed doors.
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The Food and Drug Administration oversees manufacturers’ postmark surveillance studies on new and significant health concerns in order to understand a device’s risks and to update policies on such risks.
Access to affordable insulin can be a matter of life and death for Americans with diabetes.
President’s Fiscal Year (FY) 2020 Budget request for the FDA
Keeping pace with technology that seems to develop at the speed of light and getting medical treatments to the people who most need them as quickly as possible while still maintaining top standards and keeping patients safe is tricky for the U.S. Food and Drug Administration, but that is its job.
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The President’s 2020 Budget includes new resources to advance the agency’s food safety program, and expand food safety monitoring