USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers
USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products
USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies
USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations
USFDA: Revising the National Drug Code Format and Drug Label Barcode Requirements
USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
USFDA's Draft Guidance: Orange Book Questions and Answers
USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
USFDA Guidance on Technical Performance Assessment of Quantitative Imaging in Radiological Device
ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation
USFDA's Guidance of Electromagnetic Compatibility (EMC) of Medical Devices
USFDA- Q&A Guide on Importation of Prescription Drugs from Canada
USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages
USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling
Generic Drug User Fee Guidance - Assessing User Fees - USFDA
USFDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations
USFDA: Activities and Engagement with the Voluntary Improvement Program