FDA
publication date
Supply Chain
Stakeholders Urged to Prioritize Interoperability Mandates as DSCSA 'Stabilization Period' Looms
The FDA is providing a one-year soft launch for the Drug Supply Chain Security Act mandates, effective November 27.
Supply Chain
Congress Warns DSCSA Could Disrupt Drug Supply
Starting Nov. 27, all drugs must be able to be tracked electronically on the unit level.
Marketing
Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the U.S. Market
Cases of vaping-related nicotine exposure reported to poison centers hit an all-time high in 2022.
Supply Chain
Drug Shortages Endanger Patients, Hike Costs
Drug shortages affect consumer costs in several ways, including higher out-of-pocket costs, higher insurance premiums, and adverse health.
Pharma
Why the Next Big Hope for Alzheimer's Might Not Help Most Black Patients
Of the 859 people infused with lecanemab during the trial, only 20 were Black.
Clinical Care
AMA Adopts More Than Dozen New Policies
The American Medical Association has created or strengthen policies to promote public health and advocate for new laws and regulations.
Marketing
Scores of Critical Lab Tests Fall Into a Regulatory Void. The FDA Is Trying to Close It.
Lab-developed tests have become increasingly popular, all while escaping the bulk of federal scrutiny over marketing and accuracy. Now, the...
Pharma
After Pandemic Delays, FDA Still Struggling to Inspect Foreign Drug Manufacturers
A ProPublica analysis of FDA data reveals that the agency only inspected 6% of the overseas plants where drugs and...
Pharma
Social Media Is Fueling Enthusiasm for New Weight Loss Drugs. Are Regulators Watching?
Competition to claim a $100 billion market for drugmakers has triggered a wave of advertising that has provoked public health...
Technology
Coalition Unveils Guidelines for Responsible AI Use in Healthcare
The Coalition for Health AI (CHAI) includes Stanford, the Mayo Clinic, Vanderbilt, Johns Hopkins, Google, and Microsoft, and is overseen...
Covid-19
FDA Experts Are Still Puzzled Over Who Should Get Which COVID Shots and When
Panel disagrees with FDA proposal that everyone get at least one shot a year, saying more information is needed.
Clinical Care
The Tests Are Vital. But Congress Decided that Regulation Is Not.
Money and lobbying help shield lab-developed tests, including prenatal screenings, from heightened federal scrutiny.