USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
USFDA's Novel Excipient Review Pilot Program
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
FDA Export Certification - Revised Guidance -US FDA
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
FY2022 User Fee Table -USFDA
Request for Comments on pre-Hatch-Waxman ‘PANDA’ applications - FDA
Guidance on Development and Submission of Near Infrared Analytical Procedures– USFDA
Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
Final Guidance - FAR Submission: Q&A – US FDA
Final Guidance on Unique Device Identification System: Form and Content of the UDI – US FDA
Draft guidance for Transdermal Adhesion Systems– US FDA
Providing Regulatory Submissions in Alternate Electronic Format – US FDA
Guidance on CMC Changes to an Approved Application- US-FDA
Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
Draft Guidance on Remanufacturing of Medical Devices- USA-FDA