Policy

FDA Requires Manufacturers to Provide Mail-Back Envelopes for Opioid Disposal

Approval of the modified Opioid Analgesic REMS is expected in 2024.

FDA Issues Final Rule for Over-the-Counter Hearing Aids

The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October.

FDA: JUUL E-Cigarette Products Banned in US

Individual consumers are not restricted from having or using JUUL products; however, the Agency will ensure compliance by retailers.

The Case for Expanding Pharmacists’ Authority to Administer Vaccines

Dr Robert Popovian discusses access to immunization services among adults in low-income communities and efforts to expand pharmacists’ authority to administer vaccines to increase vaccination rates for this vulnerable population.

ACC Statement on Respect, Civility, and Inclusion in the Cardiovascular Workplace

The American College of Cardiology has issued a policy statement regarding civility, inclusion, and respect in the cardiovascular workplace.

White House Releases Detailed Plan to Tackle the Overdose Epidemic

The Strategy focuses on 2 main drivers of the opioid epidemic: drug trafficking and untreated addiction.

FDA Considers Mail-Back Envelope as New Disposal Method for Opioids

The Agency is currently seeking public comment on this potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy.

FDA Wants to See Diverse Participation in Clinical Trials

The guidance aims to ensure that the data submitted to the Agency adequately represent the patients that will use the medical products.

Voting Behaviors of US Physicians vs the General Population From 2000 to 2020

Researchers conducted a study that compared voter turnout between physicians and the general population for US elections held between 2000 and 2020.

Expert Panel Sees Challenges With Federally Mandated Opioid Prescriber Education

During the workshop, speakers and panelists reviewed past programs that were put into place to reduce opioid prescribing, as well as trends in opioid prescribing and overdose deaths.

Calls for More Support as Physicians Face Online Harassment

The researchers conducted 1103 surveys, encompassing 464 US physicians.

Vivek Murthy Confirmed as New US Surgeon General

Murthy plans to focus on COVID-19, mental health, and substance use disorders.

FDA Identifies Most Needed Meds to Address Urgent Medical Conditions

This action was in response to an executive order issued on August 6, 2020 aimed at protecting the public against outbreaks of emerging diseases and chemical, biological, radiological, and nuclear threats.

Can Advocacy Groups Provide Useful Patient-Centered Data?

A survey presented during ASCO20 found that patients who considered themselves adequately informed felt “in control” most days.

Back to Basics: Focus on Risk Assessments for HIPAA Compliance

Regardless of the challenges a smaller group might have, a risk assessment is a baseline for any HIPAA program. The cost of this assessment is considerably less than a HIPAA fine.

UK Patients Hospitalized With COVID-19 Are More Often Male

Patients hospitalized with COVID-19 are more often male and frequently have comorbidities.

US Government Seeks Deal With Private Industry to Boost Supply of Medical Equipment

In an effort to prevent the United States from again struggling to have enough medical supplies in a pandemic, the federal government is seeking to make a five-year deal with U.S. manufacturers.

FDA Slashes Number of Approved Chinese Makers of N95 Masks

The number of mask makers in China approved to make N95-type masks for U.S. health care workers was slashed from 80 to 14 by the FDA on Thursday.

Racial/Ethnic Disparities in End-of-Life Care in a Medicaid Population

This study focused on a cohort of nonelderly Medicaid beneficiaries with stage IV breast or colorectal cancer who resided in New Jersey.

Transmission of SARS-CoV-2 From Patients to Healthcare Workers

Among 121 healthcare personnel exposed to a patient with unrecognized COVID-19, 43 became symptomatic and 3 tested positive for SARS-CoV-2.