Regulatory Oversight, Pharmaceutical Industry, Center for Drug Evaluation and Research (CDER)

CBER Director Resigns from FDA, Commissioner Makary’s Recent Remarks on FDA Staffing Cuts, CBER Hiring Data, and Additional...

Venable LLP on 8/4/2025

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more

HHS Finalizes Staffing Cuts, New CDER Director, CDER Hiring Data, and New AI Councils at FDA

Venable LLP on 8/4/2025

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more

FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)

McDermott Will & Schulte on 5/1/2024

On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more

Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight

Hogan Lovells on 1/29/2021

The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due to the pandemic, FDA has...more

Five key takeaways from the Senate hearing on FDA oversight of foreign drug manufacturing

Hogan Lovells on 6/5/2020

The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...more

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

Hogan Lovells on 12/28/2018

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more

The FDA now offers cGMP Declarations

Hogan Lovells on 10/15/2018

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

Hogan Lovells on 3/1/2017

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Regulatory Oversight › Pharmaceutical Industry › Center for Drug Evaluation and Research (CDER)

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