Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
ICH M11 Guidance: Tech Spec - Clinical Electronic Structured Harmonised Protocol (CESHARP)
SFDA MD Guidance: Requirements for Clinical Trials of Medical Device
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program
USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations
USFDA Guidance: Homeopathic Drugs Products
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
UK MHRA: MD Guidance - Register Medical Devices to Place on the Market
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug