For 35 years, the FDA has placed onerous restrictions on the only drug it has ever approved for treatment-resistant ...

Advocates and clinicians say that patients are still having trouble getting refills, even though the FDA has lifted REMS for ...

However, among these, only one — clozapine — is subject to the FDA’s stringent REMS mandate, despite similar risks associated with other drugs. Beyond the logistical challenges of ...

Click in for more news from The Hill{beacon} Health Care Health Care   The Big Story How RFK Jr. could restrict abortion ...

The REMS, originally designed to reduce the risk ... bloodwork and for pharmacies to verify results before dispensing the drug. They also recommended ending the mandatory education for providers ...

Only drugs with inpatient-applicable REMS requirements were included in the initial evaluation. Of the 145 drugs evaluated, 123 were excluded from the project because the associated REMS were ...

Most also said that mandatory blood testing was necessary, but it created a burden and medication delays. In 2024, an FDA advisory committee voted to eliminate the clozapine REMS; the agency has ...

Secretary Robert F. Kennedy Jr. has suggested that he is open to restricting access to abortion medication, the primary ...

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has suggested he is open to restricting access to abortion medication, the primary method used for abortions across the U.S. Kennedy ...