ScienceAlert

FDA to Remove 'Black Box' Warnings From Menopause Hormone Therapy. Here's Why.

For more than 20 years, hormone therapy for menopause has carried a warning label from the Food and Drug Administration ...
PharmExec

How the FDA Commissioner’s National Priority Vouchers Reshape Manufacturing, Pricing & Global Strategy

The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and ...

FDA names longtime cancer scientist Pazdur to lead drug center

The Food and Drug Administration has named a longtime regulator of cancer medications to lead the agency’s drug center ...

I Am a Drug Historian. Trump Is Wrong About Fentanyl in Almost Every Way.

The Democrats weakened the borders, allowing Mexican drug cartels to smuggle fentanyl into the United States, where it ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Manila Standard

FDA asks public not to buy or sell unauthorized health products, report violators

The Food and Drug Administration (FDA) has cautioned the public not to buy or sell any health product that does not have FDA ...
Pharmaceutical Technology on MSNOpinion

FDA inspection reveals critical supply chain vulnerabilities

Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into ...
United Nations Office on Drugs and Crime

Better quality of drug use disorder treatment in Indonesia

Indonesia was exposed to Quality Assurance Mechanisms for the Treatment and Care of Drug Use Disorders (QA) [4] in 2018 and ...
JD Supra

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design

The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...

2 Quality Healthcare Stocks That Could Build a Strong Foundation for Beginner Investors

Global populations are aging, a reality that is leading to increased demand for healthcare services, chronic disease ...

FDA recall of blood pressure pills due to cancer-causing contaminant may point to higher safety risks in older generic drugs

(THE CONVERSATION) A generic blood pressure drug called prazosin, made by Teva Pharmaceuticals, is being recalled by the Food and Drug Administration because it contains elevated levels of ...

Colorado doctors explain benefit after Trump announces plan to lower GLP-1 drug prices

President Donald Trump says Americans could soon pay far less for GLP-1 medications used for diabetes, obesity, and heart ...