Regulatory Blog

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