USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A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ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation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 Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication
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
USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide
USFDA Guidance on Electronic PostMarketing Safety Reporting
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
FDA's MAPP on Complex Product Classification for Generic Development
FDA Guidance:Providing Submissions in Electronic & Non-Elec Format—Promotional Labeling &Advertising