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
USFDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
USFDA Guidance: Platform Technology Designation Program for Drug Development
USFDA Med Dev: Guidance on Remanufacturing of Medical Devices
USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A