FDA orders tissue-recovery firm to stop manufacturing
This article was originally published in RAJ Devices
The US Food and Drug Administration (FDA) has ordered a US human tissue-recovery firm based in Raleigh, North Carolina and its owner, to stop all manufacturing operations after inspections found serious deficiencies in its manufacturing practices. Donor Referral Services and its owner, Philip Guyett, were also ordered to retain the human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered on or after 25 May 2005 and which were still in the company's possession.
You may also be interested in...
The EU has published an action plan that is intended to upgrade the bloc’s intellectual property framework while ensuring that goods such as medicines and vaccines are made as widely available as possible. The initiative is part of wide-ranging plans to support member states’ recovery from the pandemic crisis and help ensure the EU’s resilience to future health threats.
Execs On The Move: New CEO For Humacyte; Internal Moves At Trinity Biotech, CVRx, Oventus Medical And Cancer Genetics
Trinity Biotech's new CFO is an internal move; Humacyte replaces CEO; chief strategy officer role for former CVRx CFO; and more.
Teva received a “package of commercial side-deals” for agreeing to halt generic competition to Cephalon’s Provigil (modafinil) throughout the EU, which it “would not have achieved without committing to staying out of the market,” according to findings by the European Commission.