Regulatory Blog

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

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: eCTD v4.0 Implementation Guide published

USFDA Guidance: Pharmacogenomic Data Submissions

USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A

Swissmedic Guidance: Requesting Certificate of a Pharmaceutical Product (CPP)

Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System

EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials

Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products

USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens