Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
Shortages 2025: Geopolitics, severe weather fuel uncertainty
Tariff threats, lingering storm impacts and regulatory uncertainty are creating challenges for supply in the automotive, medical and food sectors.
Premarketing Risk Assessment
Guidance for Industry – Premarketing Risk Assessment, Clinical/Medical
Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy
Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide…
M4S: The CTD — Safety
International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary)
PetSmart upgrades inventory tracking to boost in-store operations
The pet retailer aims to enhance its order fulfillment capabilities by using GreyOrange’s gStore platform.
Research in Progress | Office of Prescription Drug Promotion (OPDP) Research
Research in Progress | Office of Prescription Drug Promotion Research
Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research
Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research
UPS SurePost’s Postal Service split sparked by service, cost worries
UPS executives acknowledged the shift could lead to a loss of customers, but touted upsides in making those deliveries in-house.