Maarika Kimbrell

Morgan Lewis

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Latest Posts › Disclosure Requirements

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FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

7/16/2025 / Biosimilars , Disclosure Requirements , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Pharmaceutical Patents , Publicly-Traded Companies , Securities and Exchange Commission (SEC) , Whistleblowers

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

1/28/2025 / Civil Monetary Penalty , Clinical Trials , Disclosure Requirements , Enforcement Actions , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , Reporting Requirements , Securities and Exchange Commission (SEC)

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