USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products
ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
UK MHRA: Guidance on Established Medicines Marketing Authorisation Application Process Changes
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
EMA: QRD updation and Product-Information Templates Updation
UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine
South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts
USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"
Australia TGA: eCTD AU module 1 and regional information
USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers