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Prescription Drugs › Biologics › Enforcement Actions

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Holland & Knight LLP

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Holland & Knight LLP on

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

American Conference Institute (ACI) on

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Arnall Golden Gregory LLP

You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward

Arnall Golden Gregory LLP on

Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product....more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 3 of 3)

Mintz - Health Care Viewpoints on

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

Mintz - Health Care Viewpoints on

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

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