The U.S. Food and Drug Administration and the European Medicines Agency have launched a joint initiative to share information on bioequivalence studies in generic drug approval applications.
Supply Chain
The U.S. Food and Drug Administration and CMS announced an extension on their joint Parallel Review pilot program, according to a Regulatory Focus report.
The U.S. Food and Drug Administration has named Lawrenceville, N.J.-based GS1 US the first accredited issuing agency for unique device identifiers, according to a news release.
The U.S. Food and Drug Administration, Center for Devices and Radiological Health, has announced improvements to the medical device recalls database.
Chesire, Conn.-based Alexion Pharmaceuticals has requested that hospitals return any unused vials of Soliris Concentrated Solution for Intravenous Infusion.
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Germany-based Siemens and New York-based Pfizer have entered a master collaboration deal to design, develop and market in vitro diagnostic tests for Pfizer's therapeutic products, according to a news release.
Franklin, Tenn.-based RyMed Technologies and Brentwood, N.Y.-based Medical Action Industries have signed a supply agreement, according to a news release.
Ft. Lauderdale, Fla.-based Mako Surgical Corp. has signed off on a $1.65 billion merger agreement with Kalamazoo, Mich.-based Stryker Corp., according to a news release.
Montreal, Canada-based Valeant Pharmaceuticals will acquire Hayward, Calif.-based Solta Medical at a total transaction value of about $250 million, according to a NASDAQ report.
The global medical device packaging market is expected to hit $25.7 billion by 2017, growing at an annual compound growth rate of 5.9 percent, according to an RnR Market Research report.