Articles related to REGULATORY AFFAIRS

Pharmacists’ ability to provide off-label vaccines may be severely constrained… IDSA calls on insurers to continue covering COVID vaccines consistent with multiple medical society recommendations.

This updated indication now allows the use of upadacitinib prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least 1 approved systemic therapy.

“The data on leucovorin isn’t very strong… At best it can be mildly beneficial in some patients with autism. It’s not going to cure it. It’s just going to cause a massive headache for rheumatologists since they actually need to prescribe leucovorin to people with RA on methotrexate who can’t tolerate folic acid.” —Family medicine physician

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

Lifesaving research projects on cancer, vaccine hesitancy, and health equity are being denied funding for political reasons.

Telehealth barriers include legal and regulatory issues at state and federal levels, with widespread adoption hampered by licensing portability challenges and reimbursement limitations.