Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal
Irelands HPRA's: Guide to Fees for Human Products
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
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)
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
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
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure
Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
SFDA Guidance: Conditional Approval for Medicinal Products for Human Use
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation