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Latest posts
Last updated about 13 hours ago
PDUFA and BsUFA Quarterly Hiring Updates
about 18 hours ago
PDUFA and BsUFA Quarterly Hiring Updates
FDA In Brief: FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse
about 19 hours ago
FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse...
CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
about 19 hours ago
ORA and CDER agree to replace and/or withdraw CPGs in favor of...
FDA In Brief: FDA issues 57 product-specific guidances, including 19 laying out path for developing generics to hard-to-copy “complex” medicines
about 19 hours ago
FDA is posting 57 product-specific guidances to help industry generate evidence needed...
Cohance Lifesciences Limited - 718812 - 01/30/2026
about 19 hours ago
CGMP/Finished Pharmaceuticals/Adulterated
HTO Nevada, Inc. dba Kirkman - 719074 - 01/27/2026
about 19 hours ago
CGMP/Finished Pharmaceuticals/Adulterated
FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
about 20 hours ago
FDA releases guidance on how remote interactive evaluations will be requested by...
FDA in Brief: FDA warns company for putting consumers at risk through distribution of non-compliant and misbranded drug ingredients
about 20 hours ago
FDA issued a warning letter to Professional Compounding Centers of America Inc...
FDA In Brief: FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research
about 21 hours ago
FDA has issued draft guidance describing the agency’s current thinking on several...
FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities
about 21 hours ago
FDA and Syapse presented Real-World Data at the American Association of Clinical...
FDA Rare Disease Innovation Hub
1 day ago
FDA created the Rare Disease Innovation Hub (the Hub) to serve as...