Posted by MHRA: Draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions
Philippines FDA: Full implementation of eServices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO and Sponsor
Philippines FDA: Online cascading and pilot implementation of the FDA RRD portal for the issuance of License to operate (LTO) and Certificate of Facility Registration (CFR) of radiation facilities
FDA: Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers
EDQM: RECOMBINANT VIRAL VECTORED VACCINES FOR HUMAN USE
Swissmedic: Adaptation of guidance documents Fast-track authorisation procedure HMV4 and Temporary authorisation of human medicinal products HMV4
Swissmedic: Changes to the guidance document Product information for human medicinal products HMV4
Danish Medicines Agency: Whistleblowing scheme of the Danish Medicines Agency
EMA encourages companies to submit type I variations for 2020 by end of November
UK MHRA: Using the UKNI marking from 1 January 2021
UK MHRA: Placing a medical device on the EU market, CE marking for the EU market after the end of the transition period
FDA: Risk Evaluation and Mitigation Strategy Assessment Summary for Web Posting; Establishment of a Public Docket; Request for Comments
FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection
FDA: Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
FDA: Insanitary Conditions at Compounding Facilities Guidance for Industry
PMDA: Pharmaceuticals and Medical Devices Safety Information
TGA: Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
Malaysia Medical Device Authority: New Search System Announcement
FDA: Regulatory Considerations for Microneedling Products
FDA: EUA for COVID antibody calls for additional plant oversight
Swissmedic: Clinical trials on medicinal products – Pandemic by SARS-CoV-2
UK MHRA: Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19
Swissmedic: Potential nitrosamine contamination: request to perform a risk evaluation
EMA: Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines
EMA: Consideration on core requirements for RMPs of COVID19 vaccines
EC: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
FDA: Electromagnetic Compatibility (EMC) 2 of Medical Devices (draft guidance)
FDA: Certificates Of Confidentiality (Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff)
NIH: Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
TGA: Post-market review of face masks: ARTG entries subject to market actions
HSA: Public Consultation on the Proposed Regulation for Cell, Tissue and Gene Therapy Products under the Health Products Act
TGA: Sponsors advised of transition to eCTD-only
FDA: COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
EMA: Remote pharmacovigilance inspections of MAHs during a crisis situation- Points to consider
FDA: Product-Specific Guidances for Generic Drug Development
EDQM: COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs
EMA: Guideline on the clinical evaluation of anticancer 6 medicinal products
EC: COMMISSION RECOMMENDATION on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection
HPRA: Guide to Routine Import/Export of Tissues and Cells for Human Application Involving Countries Outside the European Union
EMA: EMA considerations on COVID-19 vaccine approval
FDA: Letter of Authorisation – EUA for Baricitinib in combination with Remdesivir
FDA: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (draft guidance)
FDA: Cross Labeling Oncology Drugs in Combination Regimens (draft guidance)
FDA: Clinical Drug Interaction Studies With Combined Oral Contraceptives (draft guidance)
Pfizer And Biontech Conclude Phase 3 Study Of Covid-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
WHO: Good manufacturing practices 6 for investigational products (draft working document for comments)
TGA: Low levels of contamination with N-nitrosodimethylamine (NDMA)
Philippines FDA: Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for Compassionate Special Permit (CSP) Application for Drug Products
EC: A pharmaceutical strategy for Europe
FDA: Qualification Process for Drug Development Tools
FDA: Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
ICMRA: Statement on continuation of vaccine trials
FDA: Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate