Devices

FDA Cautions Providers About Olympus Import Alert

FDA is alerting health care providers about an import alert for certain Olympus Medical Systems medical devices manufactured in Japan. “Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency says. “Therefore, the FDA has issued an import alert to prevent future shipments of certain devices from entering the United States, including specific models of:

Ureterorenoscopes, which are used to perform various diagnostic and therapeutic procedures within the urinary tract,
Bronchoscopes, which are used to perform various diagnostic and therapeutic procedures in the respiratory tract,
Laparoscopes, which are used to perform various diagnostic and therapeutic procedures in the abdomen and pelvis,
Automated endoscope reprocessors, which are used to reprocess various endoscopes,
Ingestible telemetric gastrointestinal capsule imaging systems, which are used for visualization of the small bowel mucosa, and
Enteroscopes, which are used to provide visualization and perform procedures within the small intestine.

Earlier this week, FDA released an Olympus 19-page Warning Letter that cited GMP issues raised during inspections of the firm’s facilities in the U.S., Japan, and Europe conducted in late 2025 (see story).

FDA Transparency Initiative Could Reshape Acquisitions: Attorneys

FDA's expanding transparency initiative could significantly change how pharmaceutical and biotechnology companies evaluate potential acquisitions, giving buyers greater access to regulatory information that could influence asset valuations, purchase agreements and the allocation of financial risk, according to attorneys at Arnall Golden Gregory (AGG). Earlier this month, FDA unveiled

BDR Pharma Sues FDA Over Generic Voquezna Exclusivity

BDR Pharmaceuticals International has filed a lawsuit against FDA, alleging the agency unlawfully extended market exclusivity for Phathom Pharmaceuticals’ acid-suppressing drug Voquezna (vonoprazan), preventing BDR from submitting an ANDA for a generic version until 5/2032. In a 10/21 complaint filed in the U.S. District Court for

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

The Partnership for Safe Medicines (PSM) has filed a citizen petition urging FDA to ban compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them. The advocacy group contends the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in

CDER Enforcement Expands Beyond Manufacturing: Attorneys

A new analysis by Hogan Lovells finds CDER enforcement activities are “substantially larger, broader in scope, and more centralized than they were two years ago. Moreover, the composition of enforcement activity has shifted in ways that should prompt pharmaceutical manufacturers to reassess their compliance risks.” Examining CDER Office of Compliance’

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FDA Transparency Initiative Could Reshape Acquisitions: Attorneys

BDR Pharma Sues FDA Over Generic Voquezna Exclusivity

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

CDER Enforcement Expands Beyond Manufacturing: Attorneys