3 results

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

  January 24, 2022

  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

  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

  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 heart risks associated with the controversial diabetes drug.