USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
Swiss Medic Guidance: Document on Formal requirements
EMA Checklist: Updated Validation checklist for Type II quality variations
Pakistan DRAP Guidance: GMP for Manufacturing Sites of Drugs
South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products
Ireland's HPRA: Guide to Clinical Trial Applications
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
MHRA Guidance: Innovative Licensing and Access Pathway (updation)
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal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