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FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

"The FDA is finalizing guidance today that will help protect public health by reducing infants' exposure to inorganic arsenic, which has been associated with neurodevelopmental effects.

FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June.

FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities

"The clinical experience of people with cancer who have contracted COVID-19 is an essential resource that can help the medical community better understand the impact of the disease in this population.

FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.

FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

As a result of the challenges presented by the COVID-19 public health emergency, the FDA is extending its enforcement discretion policy which will provide manufacturers and potential sponsors an additional six months to determine if they need to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application, as appropriate.

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

An EUA to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System

The White House Guidelines for Opening Up America Again are providing us a roadmap for optimizing operations and new work arrangements, as well as the Centers for CDC guidance for protecting workplace exposures to COVID-19 in non-healthcare settings.

FDA COVID-19 Update

Today, a U.S. District Court in Florida granted a motion for default judgment and a permanent injunction against the Genesis II Church of Health and Healing, Jonathan Grenon, and Jordan Grenon for violating federal law by distributing their product, "Miracle Mineral Solution