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…

More Than 60,000 Camp Lejeune Water Poisoning Claims Submitted by Injured Veterans, Family Members: Report (Posted 6 days ago)

A new report indicates the U.S. Navy is struggling to process tens of thousands of Camp Lejeune water poisoning claims due to a lack of resources.

Motion Filed to Centralize Bard Implanted Port Lawsuits in Federal Court System (Posted 6 days ago)

A group of plaintiffs have filed a motion with the U.S. JPML seeking consolidation of all Bard implanted port lawsuits before one judge for pretrial proceedings.

Hearing Loss Lawsuit Filed Against Tepezza Manufacturer Over Failure to Warn (Posted 7 days ago)

A Tepezza hearing loss lawsuit accuses the manufacturer of failing to provide adequate warning about the risks of the thyroid eye disease drug.

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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