USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs
USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide
USFDA Guidance: Electronic Submissions for De Novo Requests and Section 513(g) Requests for Information
USFDA Guidance: Predetermined Change Control Plans for Medical Devices
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
USFDA Guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
FDA (ICH) Guidance: M12 Drug Interaction Studies & Questions and Answers
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
USFDA Guidance: Container Closure System and Component Changes: Glass Vials and Stoppers
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
USFDA Guidance: Pediatric IBD Drug Development, Clin.Pharmacology Considerations and BP-Pulse Donor Eligibility Requirements
USFDA Guidance: Application User Fees for Combination Products
USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD
USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers
USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products
USFDA: Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product
USFDA Guidance: Facility Readiness: Goal Date Decisions Under GDUFA