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
Over the last eight months, the US Federal Trade Commission (FTC) has focused on what it characterizes as “improper” Orange Book listings and the impacts of such listings on generic entry....more
The US Federal Trade Commission (FTC) sent letters on November 7, 2023, accusing 10 companies of improperly listing drug delivery device patents in the US Food and Drug Administration (FDA) Orange Book, stating that the FTC...more
The US Federal Trade Commission (FTC) recently issued a policy statement “to put market participants on notice that the FTC intends to scrutinize improper Orange Book listings” and take “actions against companies and...more
Enacted on December 29, 2022, the Consolidated Appropriations Act (the year-end omnibus spending bill) includes the Food and Drug Omnibus Reform Act (FDORA), which enhances the Food and Drug Administration’s authority in...more
On January 24, 2023, the Food and Drug Administration published a notice in the Federal Register to “address the uncertainty” created by the US Court of Appeals for the Eleventh Circuit’s September 30, 2021, decision in...more
On June 24, 2022, the US Food and Drug Administration issued a draft guidance document on the Considerations for Rescinding Breakthrough Therapy Designation. The guidance explains how the FDA may rescind a drug or biologic...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On March 15, 2022, the US Food and Drug Administration issued a pair of draft guidance documents in the gene therapy space.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
The President has signed a $2 trillion relief package, the "Coronavirus Aid, Relief, and Economic Security Act" (CARES Act). The CARES Act is intended to provide "emergency assistance and health care response for individuals,...more
3/29/2020
/ Affiliated-Business Arrangements ,
Business Interruption ,
CARES Act ,
Coronavirus/COVID-19 ,
Economic Injury Disaster Loans ,
Employee Retention ,
Executive Compensation ,
Federal Loans ,
Financial Stimulus ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Relief Measures ,
SBA ,
SBA Lending Programs ,
Small Business ,
Tax Relief