Regulatory Blog

USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants

ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products

USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling

USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions

USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide

USFDA Guidance: Controlled Correspondence Related to Generic Drug Development

USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter

USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program

USFDA Guidance: Homeopathic Drugs Products

USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1

USFDA Guidance: Statistical Approaches to Establishing Bioequivalence

USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug

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)