US: Minimal Manipulation and Homologous Use Products
US: Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients
US: De Novo Classification Process (Evaluation of Automatic Class III Designation
US: Medical Device Development Tools; Helping to Speed Medical Device Evaluation and Approval with FDA’s voluntary Medical Device Development Tools (MDDT) program can help, to determine if the tool measures what it’s supposed to measure, and does so reliably.
US: Manual of Policies and Procedures (MAPP) 6010.11 Developing and Issuing Drug Trial Snapshots The purpose of this MAPP is to ensure the FDA’s implementation of the Drug Trial Snapshots (DTSs)
US: Electronic Study Data Submission; Data Standards; Support for most current B3-format annual Version Update of World Health Organization Drug Global
US: Deciding When to Submit a 510(k) for a Software Change to an Existing Device
US: Deciding When to Submit a 510(k) for a Change to an Existing Device
US: Product-Specific Guidance; the availability of additional draft and revised draft product-specific guidance on providing product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).
US: Medical Devices; Immunology and Microbiology Devices; Classification of the BCR-ABL Quantitation Test
US: Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System
US: Medical Devices; Immunology and Microbiology Devices; Classification of the Aquaporin-4 Autoantibody Immunological Test System
US: Medical Devices; Gastroenterology-Urology Devices; Classification of the Enzyme Packed Cartridge
Brazil: Good Distribution and Good Storage Practice Certification, 14-Aug-2013 (Official Consolidated Version up to Amendments Brought by Resolution RDC 183 of 17-Oct-2017)
Brazil: Resolution RDC 39; Establishes Administrative Procedures for the Granting of Good Manufacturing
EU: EDQM Highlights Importance of Guiding Blood Establishments (BES) in Implementing Quality Standards
EU: Clinical Trial Regulation and EMA Transparency Policy
EU: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1, adopted
Canada: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times
Canada: Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Canada: Guidance Document: Certified Product Information Document - Chemical Entities (CPID-CE)
Canada: Guidance Document: Addendum - Quality (Chemistry and Manufacturing) Guidance
Australia: Strengthening the Assessment of Medical Devices and Information for Consumers
Australia: Labelling Changes: Information for Health Professionals
Australia: Regulation of Autologous Cell and Tissue Products some of these products will be subject to regulation as biologicals
Japan: PSEHB/PED: Reference Concerned by Guidelines for the Clinical Evaluation of Antibacterial Drugs
Japan: PSEHB/PED No. 1023/3: Guidelines for the Clinical Evaluation of Antibacterial Drugs, Revised version
Japan: MHLW Ordinance No. 116/2017: Amendments of Good Post-Marketing Study Practice
Taiwan: PIC/S; Guide to Good Manufacturing Practice for Medicinal Products
Taiwan: MOHW Letter No.1061409034; To Promote the E–Platform for Review & Submission
EU: EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
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