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New Guidance › Reporting Requirements › Food and Drug Administration (FDA)

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

Alston & Bird on

Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Health Care Compliance Association (HCCA) on

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

Robinson+Cole Health Law Diagnosis

FDA Enhances PMSR For Combination Products

Robinson+Cole Health Law Diagnosis on

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...more

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