On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more
1/22/2024
/ Canada ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Florida ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Imports ,
Life Sciences ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
The Big Picture -
On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more
12/20/2023
/ Abortion ,
Alliance for Hippocratic Medicine v Food and Drug Administration ,
Article III ,
Certiorari ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Human Rights ,
Life Sciences ,
Medical Necessity ,
Patient Access ,
Pregnancy ,
Prescription Drugs ,
REMS ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Standing ,
Women's Rights
On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills...more
8/23/2023
/ Abortion ,
Department of Justice (DOJ) ,
Drug Distribution ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
REMS ,
Reproductive Healthcare Issues ,
SCOTUS ,
Women's Rights
Prenatal vaccines—those administered during a pregnancy—provide crucial protections to pregnant women and/or newborns against communicable diseases such as whooping cough and influenza. Additional prenatal vaccines are in...more
5/17/2023
/ Affordable Care Act ,
Children's Health Insurance Program (CHIP) ,
Fee-for-Service ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
MCOs ,
Medicaid ,
Medicare ,
Patient Access