Drugs - October 2017

November 1, 2017

  • 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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