Tag Archives: guidance

Connecticut Governor Lamont Releases Guidance for Dentists Expanding Services Beyond Emergency-Only Care

On May 17, 2020 Connecticut Governor Ned Lamont – in conjunction with the Department of Public Health (DPH) – released a guidance document for resuming non-emergency dental procedures (the “Guidance”). The Guidance notes that while dental practices were never subject to an executive order to close, the governor’s office and DPH had both strongly encouraged the suspension of all elective procedures and routine non-emergency care. Accordingly, as certain businesses in the state begin to reopen starting on May 20th, the Guidance is designed to inform dental practitioners on …

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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