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Insulin Gains New Pathway to Increased Competition

The U.S. Food and Drug Administration reports today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.

Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.

FDA Provides Guidance on Production of Alcohol-Based Hand Sanitizer to Help Boost Supply, Protect the Public

As part of the U.S. Food and Drug Administration's ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

2020 Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

Coronavirus (COVID-19) Update: FDA Gives Flexibility to NYS Department of Health, FDA issues Emergency Use Authorization Diagnostic Testing

Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency's ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).

Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections

Today, the U.S. Food and Drug Administration (FDA) provided an update on the status of FDA inspections outside of the U.S. in response to the COVID-19 outbreak. After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications

The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes, which was recommended in previous guidance and has typically been done through cardiovascular outcome trials.

Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

These products are unapproved drugs that pose significant risks to patient health and violate federal law.