Regulatory Issues

Latest News

Increased Flexibility Seen in Preapproval Evidence for New Drugs

Twenty-eight percent of trials used historical, external, or other control; nearly half used surrogate measure as a primary end point

FDA Declines EUA Request for Fluvoxamine for COVID-19 Treatment

By

Brian Park, PharmD

The totality of the evidence led the FDA to determine that the criteria for issuing an EUA had not been met.

Use of Extrapolation Common in FDA New Drug Approvals

Extrapolation from pivotal trial data to broader U.S. Food and Drug Administration (FDA)-approved indications is common.

Acetaminophen Label Changes Not Linked to Accidental OD Admission

Modifications to labelling standards for acetaminophen, were not associated with trends in hospital admission for accidental acetaminophen overdose.

White House Unveils Plan to Lower Cost of Prescription Drugs

By

Steve Duffy

FDA Commissioner, Scott Gottlieb MD, said, “The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs.”

April 28 Is Drug Take Back Day

By

Florence Chaverneff, PhD

April 28, 2018 is National Prescription Drug Take Back Day.

How San Francisco Is Tackling the HIV/HCV and Opioid Epidemics

By

Florence Chaverneff, PhD

Katie Burk, MPH, presented measures undertaken by the city of San Francisco to provide integrated responses to the concurrent HIV/HCV and opioid public health epidemics.

Antimicrobial Resistance Research Threatened by Budget Cuts

Proposed budget cuts from the Trump administration can seriously hamper efforts to address antimicrobial resistance.

New Bill Before Congress Aims at Addressing Antibiotic Resistance Problem

By

Linda Peckel

Antibiotic resistance has a high mortality rate, and the problem is growing as manufacturers retreat from investing in new drugs and diagnostic tests.

Imported Food Tied to Increase in Foodborne Disease Outbreaks

During 1996-2014, a total of 195 outbreak investigations implicated an imported food, resulting in 10,685 illnesses, 1,017 hospitalizations, and 19 deaths.

Health Care Spending Up Due to Rising Costs of Prescription Drugs

According to the 2015 Health Care Cost and Utilization Report, prescription drugs are the fastest growing expense.

American Red Cross Sounds Alarm for Blood Donations

There’s currently less than a five-day supply, group says.

Physicians May Be Misled About FDA ‘Breakthrough’ Drug Designation

Many believe meds supported by stronger evidence than the law requires to achieve designation.

Stakeholders Discuss Need For Guidelines to Assess Aging Physicians

Reps from physician, hospital, patient safety organizations explore need for national guidelines.

SCOTUS Decision: States Can’t Force Health Care Data Release

Supreme Court rules states can’t force health insurers to turn over data.

2016 Adult Immunization Schedule Gets Green Light

Changes to schedule for HPV, pneumococcal, and meningococcal vaccines.

Will Health Care Legislation Change This Year?

Bipartisan issues could be on agenda, including elimination of proposed tax on medical devices.

Scope-Related Infections Even Higher Than Previously Thought

Last year, the U.S. Food and Drug Administration said contaminated duodenoscopes were associated with 142 patient infections.

National Action Plan Addresses Multidrug-Resistant Tuberculosis

By

Colleen Hall

Officials with IDSA urge “specific benchmarks” for treating and preventing spread of MDR-TB.

Higher Hospital Prices Noted in U.S. ‘Monopoly Markets’

Hospital prices positively associated with indicators of hospital market power.