FDA Law Blog: Biosimilars

MAY 13, 2024

It was Congress that intervened in 2022, to mandate FDA to issue or revise its 2017 guidance on considerations for the use of RWD and RWE to support regulatory decision-making for devices to clarify its regulatory expectations. This guidance, when finalized, will replace the original version of this document finalized in 2017.

Medical Records 111

Medical Records Documentation 111

FADIC

OCTOBER 20, 2023

Medication Therapy  Review (MTR) ■ A list of suggested questions to use when conducting a medication therapy review in a geriatric patient. * What medication are prescribed by any specialists you may see? What medication do you take that do not require a prescription? ■ How to handle missed doses.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medical Records Medication Therapy Management (MTM) 52

Pharmacy Joe

NOVEMBER 14, 2021

Authors from the Cleveland Clinic Euclid Hospital recently published in AJHP their own experiences optimizing the medication-use process for fentanyl patches at a small community hospital. In 2017 the authors developed and implemented a procedure requiring an opioid status verification by a pharmacist for all fentanyl patch orders.

Hospitals 40

Hospitals Medical Records Inpatient Documentation 40

FADIC

OCTOBER 20, 2023

Personal Medication Record (PMR) Patients should be instructed to keep a record of all the medications they are prescribed, whether from the over-the-counter or as prescriptions. If possible, the patient can document the name and personal details of the physician who made the prescription. Pathway/ Protocol 5.

Health and Personal Care Stores 90

Health and Personal Care Stores Documentation Medical Records Hospitals 90