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Johnson & Johnson (J&J) has informed the SEC and Department of Justice (DOJ) that some of the firm's foreign subsidiaries may have broken a law intended to prevent corporate bribery of foreign officials.
New guidance documents prepared by three study groups of the Global Harmonization Task Force (GHTF) should help smooth the way for more expedited device approvals and ease firms' ability to comply with foreign regulations.
The kinds of information the Centers for Medicare & Medicaid Services (CMS) relies on when making coverage decisions may not be what firms expect, as one company recently found out.
Third Wave Technologies and Stratagene recently announced they had reached an out-of-court settlement regarding a case litigated in the U.S. District Court in Wisconsin in September 2005 and appealed to the U.S. Court of Appeals for the Federal Circuit.
STAAR Surgical has provided an update on the status of the firm's submission to the FDA for approval of its Visian toric implantable Collamer lens (TICL) designed to treat myopia and astigmatism.
The FDA warned Lee Laboratories for several current good manufacturing practice (cGMP) violations, most of which were repeat violations from a previous agency inspection.