Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more
1/15/2025
/ Clinical Trials ,
Compliance ,
Corporate Governance ,
Data Integrity ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Pharmaceutical Industry ,
Regulatory Authority ,
Regulatory Requirements ,
Securities Regulation ,
Shareholders ,
Warning Letters
On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products and new animal drugs. The...more
On March 15, 2022, the US Food and Drug Administration issued a pair of draft guidance documents in the gene therapy space. The first, which is specific to gene therapies incorporating genome editing (GE), was aimed at...more
On December 9, 2021, one of the nation’s top healthcare prosecutors made clear that clinical trial fraud will be a major enforcement priority of President Joe Biden’s Department of Justice. Speaking at the Food and Drug Law...more