RAPS

FDA Releases Extensive Final Q&A Guidance on Generic User Fees

The US Food and Drug Administration (FDA) has released an updated question-and-answer document intended to assist sponsors and manufacturers of generic drug products approved via the 505(j) regulatory ...
RAPS

Mail Order Pharmacies Can Lessen Generic Usage, Study Finds

Although nearly 90% of all drugs dispensed in the US are now generic drugs, a new study published in Therapeutic Innovation & Regulatory Science explores the determinants of generic substitution ...
Roll Call

Targeting FDA user fees would leave agency gutted, experts say

Health and Human Services Secretary Robert F. Kennedy Jr. and his allies rallied around removing industry influence from the Food and Drug Administration as part of their quest to Make America Healthy ...
Health Affairs

Advancing The FDA’s Human Foods Program Through Additional Authorities And User Fees

The Food and Drug Administration (FDA) lacks certain authorities and is persistently underresourced to fulfill its mission of protecting the public by ensuring that foods are safe, wholesome, sanitary ...
Los Angeles Times

Stigma only makes drug use more dangerous

This is read by an automated voice. Please report any issues or inconsistencies here. Until we stop framing all drug use and every overdose as problems of “addiction” and “substance use disorders,” we ...
The American Journal of Managed Care

Youth Drug Use Continues Historic Decline Post Pandemic

Adolescent substance use remains at record lows in 2024, extending declines first observed during the COVID-19 pandemic. Adolescent drug use in the US has continued to drop or remain stable in 2024, ...