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Adverse Events Dietary Supplements

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

Vicente LLP on

Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more

Mintz - Health Care Viewpoints

And Now For Something Completely Different: FDA Actions to Alleviate Regulatory Burdens For Product Sponsors During the COVID-19...

We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public...more

Morgan Lewis

FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics

Morgan Lewis on

In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more

Troutman Pepper

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

Troutman Pepper on

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

Arnall Golden Gregory LLP

Show Me, Show Me, Show Me: FDA to Post Adverse Event Report Data Associated With Certain Products

On December 7, 2016, the Food and Drug Administration announced that it would post on its website adverse event reports from January 2004 to the present for food (including food additives, color additives, and dietary...more

Faegre Drinker Biddle & Reath LLP

FDA's Public Posting of Adverse Event Reports: Four Things to Know

As part of a new initiative, the U.S. Food and Drug Administration (FDA) will begin publicly posting all consumer reports of adverse events related to food, dietary supplements and cosmetics. Here are four things companies in...more

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