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India Finalizes Rules Regarding Compensation for Subjects Injured in Clinical Trials and Post-Trial Access to Study Drugs

Since 2013, India’s clinical trials regulatory framework has undergone continuous, significant changes to bolster protections for clinical trial participants. In an effort to clarify these evolving requirements relating to clinical trials, on February 1, 2018, India’s Ministry of Health and Family Welfare (the “MoHFW”), in supersession of India’s Drugs and Cosmetics Rules, 1945, issued new draft rules pertaining to clinical trials (the “2018 Draft Rules”).

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CMS and OIG Propose Extension of Federal Stark Exception and Anti-Kickback Safe Harbor for Electronic Health Record Donations

Practices: Health Care

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