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Time Extensions Food and Drug Administration (FDA)

Venable LLP

Regulatory Freeze: FDA Pushes Back Effective Date of "Healthy" Nutrient Content Claim Rule

Venable LLP on

On February 25, the Food and Drug Administration (FDA) announced a delay in the effective date for its final rule updating the criteria to use the "healthy" nutrient content claim on food labeling....more

Benesch

Dialysis & Nephrology Digest - January 2021

Benesch on

Congress’ year-end spending bill includes increase to Medicare physician fee schedule, surprise medical bill protection - Sweeping federal legislation signed into law on Dec. 27 combines $1.4-trillion in spending...more

Goodwin

FDA Defers Decision on Bevacizumab Biosimilar

Goodwin on

The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab). In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more...more

Mintz - Health Care Viewpoints

Further Update on FDA’s Comprehensive Regenerative Medicine Framework: November 2020 Deadline Extended by Six Months

About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not...more

Tarter Krinsky & Drogin LLP

COVID-19 Prioritized Examination

On May 8, 2020, the United States Patent and Trademark Office (USPTO) announced a new program for expediting certain COVID-19 related patent applications. Under the COVID-19 Prioritized Examination Pilot Program, the USPTO...more

McDermott Will & Emery

Update: FDA Extends Comment Period for Input on Uses of “Natural” in Food and Beverage Labeling

McDermott Will & Emery on

On December 28, 2015, the U.S. Food and Drug Administration (FDA) extended by 90 days the public comment period on the use of the term “natural” in food and beverage labeling. As discussed in an earlier post, the FDA is...more

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