USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
USFDA MD Guidance: Referencing “Device” and “Counterfeit Device”
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
USFDA Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
USFDA's Notice: CMC Development & Readiness Pilot Program
USFDA Guidance: Developing & Responding to Deficiencies - Least Burdensome Provisions
USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases
USFDA MD Guidance: Breakthrough Devices Program - Reducing Disparities in Health & Health Care
USFDA Guidances: Preapproval Inspections & Drug Manufacturing Inspections
USFDA Guidances: Topical Generic Drug Products - ANDAs
USFDA Guidance: Multiple Guidances related to Oncology
USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies
USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA