FDA Law Blog: Biosimilars

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner. Several weeks later, also based on ability to pay, the U.S.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

Putting Patients First Blog

JULY 2, 2024

The discussion focused on CMS’ 2023 listening sessions during implementation of the first round of negotiations and identified lessons learned to inform future listening sessions and broader patient engagement strategies. Prior authorization and association with delayed or discontinued prescription fills. and Keating, N.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

Putting Patients First Blog

SEPTEMBER 3, 2024

We recommend that CMS offer more specific sub-questions, similar to other questions in the document, aimed at prioritizing the identification of health disparities that may affect access to and outcomes from the selected drug. Prior authorization and association with delayed or discontinued prescription fills. and Keating, N.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52