FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

Our last two PTE-related posts concerned the issues of: (1) multiple PTEs—a topic we blogged on in 2020 , but that we have been following since the very early days of the FDA Law Blog in 2008 and 2009 (see our previous posts here , here , and here )—and (2) the Improving Regulatory Transparency for New Medical Therapies Act (“IRTNMTA”)—a topic we blogged (..)

Controlled Substances 59

Controlled Substances Hospitals 59

FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

Inpatient 59

Inpatient Hospitals Dosage Controlled Substances 59

The Thyroid Pharmacist

NOVEMBER 15, 2024

I also prefer semaglutide drugs over other weight loss drugs out there (for example, phentermine, a controlled substance that can be habit forming, or orlistat, a drug that results in fat malabsorption and “disaster pants”). 2012 Mar;166(3):477-85. 2012 Mar-Apr;18(2):179-84. Eur J Endocrinol. doi: 10.1530/EJE-11-0917.

Diabetes 75

Diabetes Immunity Immunization Compounding 75