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.
Tag Archives: REMS
The FDA has suspended a Clozapine REMS program's enforcement measures after numerous reports of patients suffering delays in getting the antipsychotic drug.
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…
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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.
The U.S. Navy has received more than 129,000 Camp Lejeune water contamination claims, according to court records.
A Bard PowerPort lawsuit accuses the manufacturers of concealing known defects and complications from patients and the medical community.