XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

FDA Approval 64

FDA Approval Clinical Trials Clinical Trials Nurses 64

Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. pharmacies. and arguably just as safe. Let’s call him John. Is the drug safe? Is it counterfeit?

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

FDA Law Blog

NOVEMBER 29, 2022

An important part of the 2022 Guideline includes CDC’s pronouncement that some laws, regulations and policies have misapplied the 2016 guidelines and likely contributed to patient harm. Clinicians should review FDA-approved labeling and weigh benefits and risks before beginning pharmacologic therapy. 2022 Guideline at 3.

Pharmacy 52

Pharmacy Drugs Regulation FDA Approval 52

XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. Viewpoints from UAE Residents Who Were Given the COVID-19 Vaccine.

Vaccination 98

Vaccination Vaccine Immune Response Manufacturing 98

Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

XTalks

AUGUST 30, 2022

Nusinersen was the first FDA-approved treatment for spinal muscular atrophy (SMA), the first approved nucleic-acid therapeutic for a neurologic disease and the first approved drug to correct defective splicing. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

Trials 83

Trials Drug Delivery Drugs Gene 83

Intouch Solutions

AUGUST 5, 2021

It, like the Nightingale Pledge for nurses, is a list of tenets that physicians abide by to uphold certain morals and to ensure healthcare professionals (HCPs) provide top-quality care to all who seek it. “I The reasons vary, but one of the most recent shortages of synthetic estrogen has largely been chalked up to a delay in FDA approval.

Marketing 52

Marketing Doctors Doctor Clinical Trials 52