Access Consortium Strategic Plan 2021-2024
On 22 June 2021 the Access consortium (comprising the national regulatory authorities of Australia, Canada, Singapore, Switzerland, and the UK) published its Strategic Plan 2021-2024.
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Clinical Trials Information System (CTIS) Highlights – June 2021
On 23 June 2021 the EMA published Issue 3 of the CTIS newsletter.
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Remanufacturing of Medical Devices
On 24 June 2021 the FDA published the draft guidance for industry and FDA staff. Comments should be submitted by 23 August 2021.
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Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
On 24 June 2021 the FDA published this draft guidance for industry. Comments should be submitted by 24 August 2021.
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Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
On 25 June 2021 the FDA published this draft guidance for industry. Comments should be submitted by 24 September 2021.
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Questions & Answers for Applicants, Marketing Authorization Holders of Medicinal Products and Notified Bodies with Respect to the Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746)
On 29 June 2021 the EMA published the Q&A guidance on implementation of the medical devices and in vitro diagnostic medical devices regulations.
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Product Management Services – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 30 June 2021 the EMA published the guidance on ISO implementation for the IDMP in Europe.
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Product Identifiers under the Drug Supply Chain Security Act — Questions and Answers
On 3 June 2021 the FDA announced the availability of the final Q&A guidance for industry.
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Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations Can Prepare for CTIS
On 7 June 2021 the EMA announced a CTIS webinar which will take place on 29 July 2021.
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Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial Data
On 8 June 2021 the US Department of Justice released update on clinical researchers’ clinical trial data scheme.
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Core Patient-Reported Outcomes in Cancer Clinical Trials
On 9 June 2021 the FDA published the draft guidance. Comments should be submitted by 9 August 2021.
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Frequently Asked Questions about Parallel Distribution
On 9 June 2021 the EMA published the Q&A guidance on parallel distribution.
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CIOMS Cumulative Pharmacovigilance Glossary
In June 2021 the CIOMS published the pharmacovigilance glossary V1.1.
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EMA Annual Report 2020 Published
On 14 June 2021 the EMA published its 2020 annual report.
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COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention
On 17 May 2021 the FDA issued this final guidance for industry.
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Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency: Questions and Answers
On 17 May 2021 the FDA issued this Q&A guidance for industry.
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Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention
On 19 May 2021 the FDA published this draft guidance for industry. Comments should be submitted by 19 July 2021.
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Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
On 19 May 2021 the FDA published this final guidance for industry and FDA staff.
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Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs
On 19 May 2021 the FDA published the draft guidance on questions regarding the Statement of Investigator Form 1572.
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ICH Q12: Implementation Considerations for FDA-Regulated Products
On 19 May 2021 the FDA published this draft guidance on the International Council for Harmonization (ICH) Q12 for industry.
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Conveying Medical Device Materials Information to Patients and Clinicians: Considerations for a Framework
On 20 May 2021 the FDA published the discussion paper on conveying information about medical device materials.
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Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
On 20 May 2021 the FDA published this draft guidance for industry.
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Bispecific Antibody Development Programs
On 24 May 2021 the FDA published this final guidance for industry.
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Notify the MHRA about a Clinical Investigation for a Medical Device
On 25 May 2021 the MHRA updated the guidance on notifying the MHRA of a proposed clinical investigation for a medical device.
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EU Medical Device Regulation Comes into Application
On 26 May 2021 the EMA announced that the Regulation (EU) 2017/745 on medical devices became applicable in the EU.
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Guidance Notes on the Management of Safety Information and Product Complaints Digital Activities
On 27 April 2021 the Association of the British Pharmaceutical Industry (ABPI) published the informal guidance notes.
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The Danish Medicines Agency’s Guidance on the Implementation of Decentralised Elements in Clinical Trials with Medicinal Products
On 4 May 2021 the Danish Medicines Agency published the guidance on decentralised clinical trials.
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FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
On 5 May 2021 the FDA published its Resiliency Roadmap for FDA Inspectional Oversight.
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MHRA Guidance on the Licensing of Biosimilar Products
On 6 May 2021 the UK MHRA published the guidance on the licensing of biosimilar products.
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Is Your eSystem Actually an eCRF (electronic Case Report Form)?
On 11 May 2021 the MHRA Inspectorate published this blog.
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Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
On 11 May 2021 the FDA published this final guidance for industry.
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Operational Application Programming Interface: Downloading Content for Analysis
On 11 May 2021 ClinicalTrials.gov announced the availability of operational API.
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Study Coordinator Charged in Scheme to Falsify Clinical Trial Data
On 11 May 2021 a US Department of Justice federal grand jury returned an indictment charging conspiracy to falsify clinical trial data.
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Draft Principles of ICH E6 Good Clinical Practice (GCP) now Available
On 19 April 2021 the ICH announced the availability of the draft principles of ICH E6 GCP.
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CDISC CDASH SAE Supplement v2.0 Released
On 21 April 2021 the CDISC announced the release of the CDASH SAE Supplement version 2.0.
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Request for Proposals for Auditors to Support Audits of MedDRA MSSO Operations
On 21 April 2021 the ICH launched a request for proposal for auditors in support of MedDRA MSSO audits.
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Clinical Trials Information System Reaches Major Milestone towards Go-Live and Application of the Clinical Trial Regulation
On 21 April 2021 the EMA announced that the CTIS is on track to go live with the application of Clinical Trial Regulation.
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Questions and Answers on the Principles of GMP for the Manufacturing of Starting Materials of Biological Origin Used to Transfer Genetic Material for the Manufacturing of ATMPs
On 23 April 2021 the EMA announced the availability of the updated Q&A guidance on GMP.
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The ICH Q3C(R8) Guideline Reaches Step 4 of the ICH Process
On 23 April 2021 the ICH announced the status of the maintenance process for the ICHQ3C(R8) guideline.
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Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases
On 26 April 2021 the FDA published draft guidance for sponsor-investigators.
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Public Web Conference Organised by the ICH E6(R3) EWG
On 26 April 2021 the ICH announced a free public web conference held by the ICH E6(R3) GCP EWG on 18-19 May 2021.
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A New Collaboration between SNOMED International and ICH Promotes Seamless Data Exchange in Support of Public Health
On 29 April 2021 the ICH announced a new collaboration between SNOMED International and ICH.
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Clinical Trials Guidance on Notification of Serious Breach
On 1 March 2021 Singapore’s Health Sciences Authority (HSA) published the clinical trials guidance on notification of serious breach.
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Development of Abbreviated New Drug Applications (ANDAs) During the COVID-19 Pandemic – Questions and Answers
On 5 April 2021 the FDA issued the final Q&A guidance on ANDAs development during COVID-19.
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Risk Management Information Day 2021
On 9 April 2021 the EMA announced a virtual event about risk management information will be held on 15 June 2021.
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Overview of Comments Received on 'ICH Reflection Paper on Proposed ICH Guideline Work to Advance Patient Focused Drug Development’
On 14 April 2021 the EMA announced the availability of the overview of comments.
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Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency — Guidance for Industry
On 14 April 2021 the FDA issued the final guidance on remote evaluations of drug manufacturing and bioresearch monitoring facilities during COVID-19.
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Updated IRIS Guide to Registration
On 15 April 2021 the EMA announced the availability of the updated IRIS guide on preliminary requirements for all IRIS submissions, including substance and research product identifier registration (version 2.6).
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MHRA Updated Guidance on Managing Clinical Trials During Coronavirus (COVID-19)
On 16 March 2021 the UK MHRA updated the guidance on managing clinical trials during COVID-19.
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EMA Updated the Pharmacovigilance System Manual
On 16 March 2021 the EMA updated the pharmacovigilance system manual version 1.3.
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EMA Updated the Clinical Trials Information System’s Training Programme
On 16 March 2021 the EMA announced the updates of the clinical trials information system’s training programme.
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Biocompatibility Assessment Resource Center
On 18 March 2021 the FDA launched a biocompatibility assessment resource center for medical devices.
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FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
On 18 March 2021 the FDA published insights from its leadership and experts into the FDA’s approach to foreign and domestic inspections.
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Guidance for Industry on MHRA’s Expectations for Return to UK On-site Inspections
On 19 March 2021 the guidance was updated on the MHRA UK risk-based GxP inspection programme.
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Inclusion/Exclusion Criteria for the “Important Medical Events” List
On 24 March 2021 the EMA announced the availability of the updated guidance related to the current version of MedDRA.
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Inspectors Grounded – A Year of Innovation
On 26 March 2021 the MHRA inspectorate shared the past year’s inspection experience and the future of innovative inspections.
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Generic Drugs Forum 2021: Lifecycle of a Generic Drug
On 30 March 2021 the FDA announced the Generic Drugs Forum webinar scheduled for 28-29 April 2021.
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MHRA Guidance on Responding to a GLP & GCP Laboratories Inspection Report
On 30 March 2021 the UK MHRA published the guidance for industry on preparing responses to GLP and GCP inspection reports.
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WS Presenting at Swiss Chinese Chamber of Commerce on 30 March 2021
Michael Zang, WSQMS Regulatory Affairs /Global Life Science Consultant, will be presenting at the Swiss Chinese Chamber of Commerce (SCCC) on March 30 2021.
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Notify the MHRA about a Clinical Investigation for a Medical Device
On 3 March 2021 the MHRA updated the guidance on how to notify the MHRA of a clinical investigation for a medical device.
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COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers
On 4 March 2021 the FDA published the final guidance for industry.
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Pilot project ‘Market Launch Intentions of Centrally Authorized Products’
On 5 March 2021 the EMA published the guidance on the practical questions and answers about the pilot project.
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Workshop on the General Data Protection Regulation (GDPR) and Secondary Use of Data for Medicines and Public Health Purposes
On 5 March 2021 the EMA published the presentation materials from the workshop held on 29 September 2020.
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Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland/Northern Ireland
On 5 March 2021 the EMA issued additional practical Q&A guidance on the applicable rules in Northern Ireland after the transition period with respect to EMA activities and medicinal products for human and veterinary use within the framework of the centralized procedure.
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Register Medical Devices to Place on the Market
On 12 March 2021 the MHRA updated the guidance on how to register medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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EMA Updated Clinical Trials Information System Development
On 12 March 2021 the EMA announced updated information on the clinical trials information system (CTIS).
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Labelling Flexibilities for COVID-19 Therapeutics
On 12 March 2021 the EMA announced the availability of guidance on labelling flexibilities for COVID-19 treatments.
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EMA Updated Q&A: Good Clinical Practice
On 16 February 2021 the EMA updated GCP Q&A by adding a new Q&A (#15) to the GCP Matters section.
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Audit Checklist – Interpretation Guide
On 16 February 2021 the EMA published the first interpretation guide to support the common audit checklist, in cooperation with the members of the joint audit programme.
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MHRA Updated Guidance on Managing Clinical Trials during COVID-19
On 17 February 2021 the MHRA updated the guidance by adding a section on the management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials.
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Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests
On 22 February 2021 the FDA issued initial guidance for test developers and FDA staff.
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Emergency Use Authorization for Vaccines to Prevent COVID-19
On 22 February 2021 the FDA issued additional guidance for industry.
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Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management services: Chapter 8 – Practical examples.
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Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe: Chapter 3
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management service: Chapter 3 – Process for the electronic submission of medicinal products information.
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Clinical Trials Regulation (EU) No 536/2014: Questions & Answers
On 24 February 2021 the European Commission released the draft Q&A on EU clinical trials regulation No 536/2014, version 3.
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MHRA Pharmacovigilance Inspection Metrics: April 2019 to March 2020
On 26 February 2021 the MHRA GPvP inspectorate published the latest inspection metrics for the period from April 2019 to March 2020.
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Chinese NMPA Released the National Medical Products Newsletter
In January 2021 the Chinese NMPA published 2021 Volume I of the National Medical Products Newsletter.
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Draft Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for PRIME Marketing Authorization Applications
On 2 February 2021 the EMA published the draft toolbox guidance. Comments should be submitted by 31 July 2021.
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EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum II
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI Addendum II – Methods for Effectiveness Evaluation. Comments should be submitted by 28 April 2021.
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EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI – Risk Minimization Measures: Selection of Tools and Effectiveness Indicators (Rev 3). Comments should be submitted by 28 April 2021.
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Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic
On 4 February 2021 the EMA published guidance version 4 with the key changes of remote source data verification.
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Reference Safety Information (RSI) for Clinical Trials – Part III
On 5 February 2021 the MHRA GCP inspectorate published the RSI blog posts Part III.
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EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 8 February 2021 the EMA published the post-authorization guidance.
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Investigational COVID-19 Convalescent Plasma
On 11 February 2021 the FDA published revised guidance for industry.
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MHRA Guidance on Pharmacovigilance Requirements for UK Authorized Products from 1 January 2021
On 12 February 2021 the guidance was published on the MHRA inspectorate blog.
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GCP Inspections Metrics Report
On 12 February 2021 the MHRA GCP Inspectorate issued the GCP inspections metrics report covering 1 April 2018 to 31 March 2019.
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FDA Released Artificial Intelligence/Machine Learning Action Plan
On 12 January 2021 the FDA released the agency’s first artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan.
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Guidelines 01/2021on Examples Regarding Data Breach Notification
On 18 January 2021 the European Data Protection Board announced the notification for public consultation. Comments should be sent by 2 March 2021.
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Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
On 19 January 2021 the FDA published the final guidance for industry.
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Commission Notice – Application of the Union’s Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Great Britain after the End of the Transition Period
On 25 January 2021 the EMA published the European Commission notice to stakeholders.
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Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe
On 25 January 2021 the European Network of Paediatric Research at the EMA’s (Enpr-EMA’s) Working Group on Ethics developed the guidance.
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FDA Updated Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 27 January 2021 the FDA updated the final guidance for industry, investigators and institutional review boards.
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Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 28 January 2021 the FDA published the final guidance for industry and FDA staff.
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Overview of Comments Received on 'Draft Questions and Answers on Data Monitoring Committees Issues' (EMA/492010/2018)
On 29 January 2021 the EMA published the overview of comments on draft Q&A on Data Monitoring Committees Issues.
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IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations
On 4 January 2021 the FDA announced the availability of the draft guidance for sponsor-investigators. Comments may be submitted until 4 March 2021.
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Human Gene Therapy for Neurodegenerative Diseases
On 5 January 2021 the FDA announced the availability of the draft guidance for industry.
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Safer Technologies Program for Medical Devices
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data
On 8 January 2021 the FDA released press on a sentence of medical doctor falsifying clinical trial data.
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COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
On 13 January 2021 the FDA published the guidance.
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