USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products
USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs
USFDA Guidance: Format and Content for OTC Monograph Order Requests
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API
UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication
Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Pakistan's DRAP: Guidelines for Good Cold Chain Management Practices
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)
Swissmedic: eCTD v4.0 Implementation Guide published
USFDA Guidance: Pharmacogenomic Data Submissions
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A