FDA's: OTC Monograph Drug User Fees for Fiscal Year 2022
SwissMedic Guidance on Packaging for Human Medicinal Products
UK (MHRA) Project Orbis Guidance Update & New Guidance on Dialysis
USFDA: 3 updated Guidance on PLAIR, VQIP & Recalls
South Africa (SAHPRA) Guidance on How to Submit Variation Applications
MHRA adds Health Technology Assessments (HTA) Tool Details to ILAP Guide
USFDA Guidance: Methods to Identify What Is Important to Patients
EU Guidelines for Good Manufacturing Practice for Medicinal Products
EU Common Standard for electronic Pproduct Information
Ireland’s HPRA - Guidance update on Submitting Mock-ups for Labels and Leaflets
US FDA CDER Guidance Agenda -Calendar Year 2022
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
Guidance for Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
Revision of PIC/S GMP Guide
USFDA Guidance on Premarket Review of Combination Products
Swissmedic Guidance on Renewals, Variations & Extensions
Ireland's guidance on New Application & Variations, Registartion Requirements,
Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling
USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review
Electronic Application Form and Cover Letter Tool - UK MHRA