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Disclosure Requirements › Abbreviated New Drug Application (ANDA) › Food and Drug Administration (FDA)

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

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

King & Spalding on

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Wilson Sonsini Goodrich & Rosati

Recent SEC Order Serves as a Reminder of the Importance of Regulation FD Compliance Programs

Wilson Sonsini Goodrich & Rosati on

On August 20, 2019, the U.S. Securities and Exchange Commission (SEC) issued a cease-and-desist order against TherapeuticsMD, a pharmaceutical company, finding that it violated Regulation FD and Exchange Act Section 13(a),...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

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