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

A new study finds that many patients are confused by the FDA's REMS drug safety program, which adds extra requirements to drugs with potentially severe side effects.
FDA Pauses Clozapine REMS Program Enforcement Due to High Volume of Patient Delays

December 16, 2021 By: Martha Garcia

The FDA has suspended a Clozapine REMS program's enforcement measures after numerous reports of patients suffering delays in getting the antipsychotic drug.
Avandia REMS Program Modified by FDA to Loosen Restrictions

November 26, 2013 By: Irvin Jackson

The FDA has announced that restrictions on prescribing and dispensing Avandia will be loosened; primarily involving the Avandia REMS Program, which was put in place due to concerns about the…

Tepezza Hearing Tests Should Have Been Recommended For Users of The Thyroid Eye Disease Drug: Lawsuit (Posted 5 days ago)

A Tepezza hearing loss lawsuit accuses the manufacturer of failing to warn doctors to conduct hearing tests, which could have helped a woman avoid permanent hearing damage.

More Than 129K Camp Lejeune Claims Filed With U.S. Navy Over Injuries Caused By Water Contamination at Marine Base (Posted 7 days ago)

The U.S. Navy has received more than 129,000 Camp Lejeune water contamination claims, according to court records.

Severity of Bard PowerPort Complications and Likelihood of Problems Occurring Were Withheld from FDA and Consumers: Lawsuit (Posted 13 days ago)

A Bard PowerPort lawsuit accuses the manufacturers of concealing known defects and complications from patients and the medical community.

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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