USFDA: Annual Summary Reporting Requirements -Right to Try Act -Final Rule
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
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's New WebPage: For Complex Generics
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USFDA's Draft Guidance: Orange Book Questions and Answers
USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A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ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation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 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