Tag Archives: REMS

FDA’s REMS Drug Safety Program Sometimes Confusing To Patients, And A Barrier To Drug Access: Study

January 24, 2022 By: Martha Garcia

Some patients believe the program is actually set up to benefit drug companies.
FDA Pauses Clozapine REMS Program Enforcement Due to High Volume of Patient Delays

December 16, 2021 By: Martha Garcia

The program was put in place to prevent cases of neutropenia, which was leaving patients vulnerable to severe and sometimes deadly infections.
Avandia REMS Program Modified by FDA to Loosen Restrictions

November 26, 2013 By: Irvin Jackson

Lawyers Propose MDL Trial Dates for Baby Formula NEC Lawsuit Starting in May 2025 (Posted 4 days ago)

A series of four bellwether claims in the baby formula NEC lawsuit MDL will be ready to go before a federal juries in May 2025, August 2025, November 2025 and February 2026 according to a proposed trial schedule agreed upon by both plaintiffs and defendants.

Change Healthcare Lawsuit Filed Over Release of Sensitive Health Information in Data Breach (Posted 5 days ago)

Pennsylvania woman claims that Change Healthcare failed to adequately protect patient health information from hackers, leaving her and others vulnerable to fraud, identity theft and other damages.

AngioDynamics Port Catheter Lawsuit MDL Established in Southern District of California (Posted 5 days ago)

U.S. JPML has transferred all AngioDynamics port catheter lawsuits to the U.S. District Court for the Southern District of California, for coordinated discovery and pretrial proceedings as part of a federal MDL (multidistrict litigation).

Tag Archives: REMS

FDA’s REMS Drug Safety Program Sometimes Confusing To Patients, And A Barrier To Drug Access: Study

FDA Pauses Clozapine REMS Program Enforcement Due to High Volume of Patient Delays

Avandia REMS Program Modified by FDA to Loosen Restrictions

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