Tag Archives: Reporting

OSHA Clarifies Position On Anti-Retaliation Rule

On October 11, 2018, the Occupational Health and Safety Administration (OSHA) issued a memorandum to clarify its position regarding whether drug testing policies and safety incentive programs would be considered violations of OSHA’s regulations. Employers may recall that, in May 2016, OSHA published a final rule that, among other requirements, prohibited employers from retaliating against employees for reporting work-related injuries or illnesses. That portion of the final rule became known as the Anti-Retaliation Rule. Almost immediately, there was confusion over which workplace safety incentive programs and post-incident drug testing policies, …

FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products

On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).

By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two …

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