Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

NMC efforts to get Dublin facility import ban lifted targeted by grand jury.

This article was originally published in The Gray Sheet

Executive Summary

NMC MANUFACTURING DOCUMENTATION AT DUBLIN FACILITY likely is being targeted by a New Jersey grand jury in its ongoing investigation of National Medical Care's Dublin, Ireland, manufacturing plant. In a "target letter" received by the company Feb. 9, the U.S. Attorney for the District of New Jersey indicates that the investigation is exploring possible criminal law violations related to NMC's effort to convince FDA to lift a January 1991 import ban on devices made at the Dublin facility. The target letter cites federal rules prohibiting firms from making false submissions to the government.

You may also be interested in...



Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning

Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.

Horizon's Teprotumumab Breezes Through US FDA Adcom, But Safety Questions Remain

Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.

UsernamePublicRestriction

Register

MT005505

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel