USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
UK MHRA: Guidance on Register Medical Devices to place on the Market
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD
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
Malaysia’s MDA : Guidance on Classification of Rehabilitation, Physiotherapy & Speech Therapy Device
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
SAPHRA Guideline: Questions And Answers Licensing Of Medical Device Establishments
Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials
Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products
USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens
ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators