"PMDA" の関連情報検索結果

Expediting Drug Development in Japan: A PMDA Perspective - Wiley



Expediting Drug Development in Japan: A PMDA Perspective  Wiley

PMDA makes case for Japan as a haven for innovation - BioWorld MedTech



PMDA makes case for Japan as a haven for innovation  BioWorld MedTech

Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement...



Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement System  PR Newswire

Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first...



Report: Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first  Regulatory Affairs Professionals Society | RAPS

Zimmer Biomet Gains Japan PMDA Approval for Iodine-Treated Hip System - The Healthcare Technology...



Zimmer Biomet Gains Japan PMDA Approval for Iodine-Treated Hip System  The Healthcare Technology Report.

VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001 - GlobeNewswire



VarmX receives Phase 1 waiver from Japanese regulator PMDA for lead asset VMX-C001  GlobeNewswire

Russia moves to withdraw from plutonium agreement with the United States - Reuters



Russia moves to withdraw from plutonium agreement with the United States  Reuters

Symplicity Spyral renal denervation system gains Japanese PMDA approval - Vascular News



Symplicity Spyral renal denervation system gains Japanese PMDA approval  Vascular News

Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceu...



Trends in good laboratory practice studies submitted for the marketing authorization of pharmaceuticals in Japan  Frontiers

ZBH Receives PMDA Approval in Japan for iTaperloc Complete and iG7 - Zacks Investment Research



ZBH Receives PMDA Approval in Japan for iTaperloc Complete and iG7  Zacks Investment Research

Nadofaragene firadenovec under regulatory review in Japan - Urology Times



Nadofaragene firadenovec under regulatory review in Japan  Urology Times

ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes - Evotec



ICH M12 2024 vs Japanese PMDA 2018 DDI Guidelines. Navigating the Changes  Evotec

BioCardia’s Positive Consultation with Japan’s PMDA - TipRanks



BioCardia’s Positive Consultation with Japan’s PMDA  TipRanks

Asia-Pacific Roundup: PMDA outlines initiatives to promote pediatric drug development in Japan - ...



Asia-Pacific Roundup: PMDA outlines initiatives to promote pediatric drug development in Japan  Regulatory Affairs Professionals Society | RAPS

MedHub-AI Receives PMDA Approval in Japan for AutocathFFR® - PR Newswire



MedHub-AI Receives PMDA Approval in Japan for AutocathFFR®  PR Newswire

PMDA more open to use of clinical data from other nations - BioWorld MedTech



PMDA more open to use of clinical data from other nations  BioWorld MedTech

BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA ...



BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA Approval for CardiAMP® Cell Therapy for Heart Failure and Helix™ Transendocardial Delivery Catheter  GlobeNewswire

Asia-Pacific Roundup: Japan’s PMDA starts offering consultation services from new US office - Reg...



Asia-Pacific Roundup: Japan’s PMDA starts offering consultation services from new US office  Regulatory Affairs Professionals Society | RAPS

Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market - Regulatory Aff...



Asia-Pacific Roundup: PMDA website promotes bringing products to Japanese market  Regulatory Affairs Professionals Society | RAPS

Asia-Pacific Roundup: PMDA discusses changes to warning letters - Regulatory Affairs Professional...



Asia-Pacific Roundup: PMDA discusses changes to warning letters  Regulatory Affairs Professionals Society | RAPS

Asia-Pacific Roundup: Japan’s PMDA shares thinking on showing clinical efficacy in chronic skin c...



Asia-Pacific Roundup: Japan’s PMDA shares thinking on showing clinical efficacy in chronic skin condition  Regulatory Affairs Professionals Society | RAPS

World's First: Breakthrough Iodine-Treated Hip Implant by Zimmer Biomet Gets Japan's Green Light ...



World's First: Breakthrough Iodine-Treated Hip Implant by Zimmer Biomet Gets Japan's Green Light  Stock Titan

BioCardia holds positive preliminary consultation with Japan’s PMDA - Investing.com



BioCardia holds positive preliminary consultation with Japan’s PMDA  Investing.com

Russia Moves to Formally Exit Landmark U.S. Plutonium Disposal Pact - The Moscow Times



Russia Moves to Formally Exit Landmark U.S. Plutonium Disposal Pact  The Moscow Times

PMDA rejects MC’s 100 acres land offer to set up Edu City - The Times of India



PMDA rejects MC’s 100 acres land offer to set up Edu City  The Times of India

WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical...



WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical products  World Health Organization (WHO)

178 Patient Trial Data: BioCardia's Breakthrough Cell Therapy for Heart Failure Advances in Japan...



178 Patient Trial Data: BioCardia's Breakthrough Cell Therapy for Heart Failure Advances in Japan  Stock Titan

Sony’s Mike Kahn elected PMDA president - Imaging Resource



Sony’s Mike Kahn elected PMDA president  Imaging Resource

cGMP Regulatory Inspections Through the Eyes of FDA, EMA and PMDA: 1 Day Virtual Course (Nov 13, ...



cGMP Regulatory Inspections Through the Eyes of FDA, EMA and PMDA: 1 Day Virtual Course (Nov 13, 2025) - ResearchAndMarkets.com  Bluefield Daily Telegraph

Russia moves to withdraw from plutonium agreement with the United States - The Hindu



Russia moves to withdraw from plutonium agreement with the United States  The Hindu

BioCardia, Inc. Completes Consultation with Japan's PMDA on BCDA-01 for Ischemic Heart Failure Tr...



BioCardia, Inc. Completes Consultation with Japan's PMDA on BCDA-01 for Ischemic Heart Failure Treatment  Quiver Quantitative

Japan offers competitive edge with clinical trial landscape and SMO approach - Clinical Trials Arena



Japan offers competitive edge with clinical trial landscape and SMO approach  Clinical Trials Arena

Plutonium Management and Disposition Agreement (PMDA), Aim, Latest News - Vajiram & Ravi



Plutonium Management and Disposition Agreement (PMDA), Aim, Latest News  Vajiram & Ravi

Korea, Japan ink medical device info sharing pact - BioWorld MedTech



Korea, Japan ink medical device info sharing pact  BioWorld MedTech

BioCardia's Revolutionary Heart Failure Treatment Advances Toward FDA Approval: Key Timeline Rele...



BioCardia's Revolutionary Heart Failure Treatment Advances Toward FDA Approval: Key Timeline Released  Stock Titan

WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again - BioSpectrum Asia



WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again  BioSpectrum Asia

PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impac...



PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage  Wiley Online Library

BioCardia (BCDA) Prepares for Formal Consultation with Japan's P - GuruFocus



BioCardia (BCDA) Prepares for Formal Consultation with Japan's P  GuruFocus

Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec - Business Wir...



Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec  Business Wire India

Asia-Pacific Roundup: Malaysia’s MDA seeks feedback on changes to medical device exemption proces...



Asia-Pacific Roundup: Malaysia’s MDA seeks feedback on changes to medical device exemption processes  Regulatory Affairs Professionals Society | RAPS

JLK wins Japan’s approval for AI stroke diagnosis tool - koreabiomed.com



JLK wins Japan’s approval for AI stroke diagnosis tool  koreabiomed.com

Easing Market Entry: Japan’s PMDA Allows Approval Filings In English - Citeline News & Insights



Easing Market Entry: Japan’s PMDA Allows Approval Filings In English  Citeline News & Insights

PMDA, HSIIDC begin pothole repair work in Panchkula - The Times of India



PMDA, HSIIDC begin pothole repair work in Panchkula  The Times of India

Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand - Regulatory Affairs Pr...



Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand  Regulatory Affairs Professionals Society | RAPS

Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion - Regulator...



Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion  Regulatory Affairs Professionals Society | RAPS

PMDA CEO conducts surprise inspection to fast-track Panchkula’s beautification drive - The Statesman



PMDA CEO conducts surprise inspection to fast-track Panchkula’s beautification drive  The Statesman

Panchkula road damaged in 2 months: DC directs PMDA, HSVP to conduct inspection, submit report - ...



Panchkula road damaged in 2 months: DC directs PMDA, HSVP to conduct inspection, submit report  The Times of India

Russia Withdraws from 25-Year-Old Weapons-Grade Plutonium Agreement - Discovery Alert



Russia Withdraws from 25-Year-Old Weapons-Grade Plutonium Agreement  Discovery Alert

Breaking the speed: Pkl’s new tabletop plan aims to slow things down - The Times of India



Breaking the speed: Pkl’s new tabletop plan aims to slow things down  The Times of India

Japan PMDA opens second overseas office in Washington - BioWorld MedTech



Japan PMDA opens second overseas office in Washington  BioWorld MedTech

PMDA giving new momentum to urban development in Panchkula: CEO Pandurang - ET Infra



PMDA giving new momentum to urban development in Panchkula: CEO Pandurang  ET Infra

Aurion Biotech receives approval from Japan’s PMDA for New Drug Application - Ophthalmology Times



Aurion Biotech receives approval from Japan’s PMDA for New Drug Application  Ophthalmology Times

Biocon share rises 4% as arm gets Japan's PMDA approval for Psoriasis drug - Business Standard



Biocon share rises 4% as arm gets Japan's PMDA approval for Psoriasis drug  Business Standard

BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Isch...



BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval  Diagnostic and Interventional Cardiology

Haryana Shehar Swachhata Abhiyan: PMDA CEO Inspects Panchkula, Orders Encroachment Removal in 3 D...



Haryana Shehar Swachhata Abhiyan: PMDA CEO Inspects Panchkula, Orders Encroachment Removal in 3 Days  The Hans India

Panchkula gets monsoon-ready, officials directed to complete flood control measures by June 15 - ...



Panchkula gets monsoon-ready, officials directed to complete flood control measures by June 15  The Times of India

Updates on Drug Regulations in Japan – Reducing Barriers to Entry for Drug Companies Entering the...



Updates on Drug Regulations in Japan – Reducing Barriers to Entry for Drug Companies Entering the Japanese Market  Winston & Strawn

Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline - Regulatory Affairs ...



Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline  Regulatory Affairs Professionals Society | RAPS

PMDA's proactive action to ensure quick drainage of rainwater in Panchkula city - Punjab Newsline



PMDA's proactive action to ensure quick drainage of rainwater in Panchkula city  Punjab Newsline

Japan Recommends Approval Of Brukinza, Balversa - Citeline News & Insights



Japan Recommends Approval Of Brukinza, Balversa  Citeline News & Insights

Russia's Parliament Backs Out of Key Nuclear Arms Reduction Treaty - Devdiscourse



Russia's Parliament Backs Out of Key Nuclear Arms Reduction Treaty  Devdiscourse

Rs 182-cr world-class shooting range in Panchkula soon - The Times of India



Rs 182-cr world-class shooting range in Panchkula soon  The Times of India

Aurion Biotech Receives Approval from Japan’s PMDA for New Drug Application - Business Wire



Aurion Biotech Receives Approval from Japan’s PMDA for New Drug Application  Business Wire

Decks cleared for recarpeting of bad roads in Panchkula - The Times of India



Decks cleared for recarpeting of bad roads in Panchkula  The Times of India

Terumo Aortic announces PMDA approval for RelayPro endovascular device in Japan - Vascular News



Terumo Aortic announces PMDA approval for RelayPro endovascular device in Japan  Vascular News

PMDA CEO inspects Panchkula city, directs removal of encroachments along roads within 3 days - Pu...



PMDA CEO inspects Panchkula city, directs removal of encroachments along roads within 3 days  Punjab Newsline

PMDA'S PROACTIVE ACTION TO ENSURE QUICK DRAINAGE OF RAINWATER IN PANCHKULA CITY - Face2News



PMDA'S PROACTIVE ACTION TO ENSURE QUICK DRAINAGE OF RAINWATER IN PANCHKULA CITY  Face2News

Aerocrine Receives Clearance for FeNO Device in Japan - respiratory-therapy.com



Aerocrine Receives Clearance for FeNO Device in Japan  respiratory-therapy.com

Belite Bio completes submission to PMDA to initiate Dragon II trial of Tinlarebant for the treatm...



Belite Bio completes submission to PMDA to initiate Dragon II trial of Tinlarebant for the treatment of adolescent Stargardt disease in Japan  Ophthalmology Times

Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystem...



Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystems  drugdiscoverytrends.com

JAPAC Drug Development: Navigating Safety & Regulatory Requirements - HIT Consultant



JAPAC Drug Development: Navigating Safety & Regulatory Requirements  HIT Consultant

The End of the Plutonium Management and Disposition Agreement: A Dark Cloud with a Silver Lining ...



The End of the Plutonium Management and Disposition Agreement: A Dark Cloud with a Silver Lining  Center for Arms Control and Non-Proliferation

Panchkula to get 'smart road' from Majri Chowk to railway station - ET Infra



Panchkula to get 'smart road' from Majri Chowk to railway station  ET Infra

Effect of chain structure on the solvent resistance in aprotic solvents and pervaporation perform...



Effect of chain structure on the solvent resistance in aprotic solvents and pervaporation performance of PMDA and BTDA based polyimide membranes  ScienceDirect.com

Terumo Aortic announces PMDA approval for Thoraflex Hybrid in Japan - Vascular News



Terumo Aortic announces PMDA approval for Thoraflex Hybrid in Japan  Vascular News

Japan’s PMDA grants clearance for Priothera to commence AML therapy - Clinical Trials Arena



Japan’s PMDA grants clearance for Priothera to commence AML therapy  Clinical Trials Arena

Enhanced 2-D MOFs nanosheets/PIM-PMDA-OH mixed matrix membrane for efficient CO2 separation - Sci...



Enhanced 2-D MOFs nanosheets/PIM-PMDA-OH mixed matrix membrane for efficient CO2 separation  ScienceDirect.com

Convergence: Understanding expedited approval pathways in Japan - Regulatory Affairs Professional...



Convergence: Understanding expedited approval pathways in Japan  Regulatory Affairs Professionals Society | RAPS

Japanese pharmaceutical regulations under review to resolve drug shortages and ensure stable supp...



Japanese pharmaceutical regulations under review to resolve drug shortages and ensure stable supply  Endpoints News

PMDA issues rains alert for September 16-19 - Associated Press of Pakistan



PMDA issues rains alert for September 16-19  Associated Press of Pakistan

Shape Memory Medical receives PMDA approval for the Impede-FX embolisation plug - Vascular News



Shape Memory Medical receives PMDA approval for the Impede-FX embolisation plug  Vascular News

Asia-Pacific Roundup: PMDA puts patients at heart of push for Japan-first approvals - Regulatory ...



Asia-Pacific Roundup: PMDA puts patients at heart of push for Japan-first approvals  Regulatory Affairs Professionals Society | RAPS

Boston Scientific receives Japanese regulatory approval for Farapulse PFA system - Cardiac Rhythm...



Boston Scientific receives Japanese regulatory approval for Farapulse PFA system  Cardiac Rhythm News

Op-ed: PMDA advances regulatory science-based “rational medicine” - Foreign Policy



Op-ed: PMDA advances regulatory science-based “rational medicine”  Foreign Policy

Pyromellitic Dianhydride (PMDA) Market Forecast - 2025 To 2033 - Business Research Insights



Pyromellitic Dianhydride (PMDA) Market Forecast - 2025 To 2033  Business Research Insights

Lecanemab Receives Priority Review Status in Japan - Biogen



Lecanemab Receives Priority Review Status in Japan  Biogen

Rheumatoid arthritis patients on persistent moderate disease activity on biologics have adverse 5...



Rheumatoid arthritis patients on persistent moderate disease activity on biologics have adverse 5-year outcome compared to persistent low-remission status and represent a heterogeneous group  Arthritis Research & Therapy

Fabrication of highly carboxylated nanofibrous aerogels under mild conditions and their protein a...



Fabrication of highly carboxylated nanofibrous aerogels under mild conditions and their protein adsorption performance  ScienceDirect.com

Novel phenylethynyl-terminated PMDA-type polyimides based on KAPTON backbone structures derived f...



Novel phenylethynyl-terminated PMDA-type polyimides based on KAPTON backbone structures derived from 2-phenyl-4,4′-diaminodiphenyl ether  Nature

Enhanced 2-D MOFs nanosheets/PIM-PMDA-OH mixed matrix membrane for efficient CO2 separation - Sci...



Enhanced 2-D MOFs nanosheets/PIM-PMDA-OH mixed matrix membrane for efficient CO2 separation  ScienceDirect.com

Explainer: What is the govt's proposed media authority and why has it invited criticism? - Dawn



Explainer: What is the govt's proposed media authority and why has it invited criticism?  Dawn

Has risk management plan system influenced the speed of package insert revisions in Japan? - Fron...



Has risk management plan system influenced the speed of package insert revisions in Japan?  Frontiers

GC Biopharma starts process for Sanfilippo syndrome treatment’s Japanese clinical trial - koreabi...



GC Biopharma starts process for Sanfilippo syndrome treatment’s Japanese clinical trial  koreabiomed.com

Rheumatoid Arthritis Pipeline Assessment 2024: Clinical Trials, FDA, EMA, and PMDA Approvals, The...



Rheumatoid Arthritis Pipeline Assessment 2024: Clinical Trials, FDA, EMA, and PMDA Approvals, Therapies, Treatment Market, Growth Prospects, and Companies by DelveInsight  Barchart.com

Biocon Biologics Secures Japan PMDA Approval For Psoriasis Drug - IPO Central



Biocon Biologics Secures Japan PMDA Approval For Psoriasis Drug  IPO Central

Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process - BioPharm I...



Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process  BioPharm International

Visualising PCP Metrics Using Grafana - Oracle Blogs



Visualising PCP Metrics Using Grafana  Oracle Blogs

Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemch...



Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemchymal® SCA in the Treatment of Spinocerebellar Ataxia in Japan  BioInformant

Sai Life Sciences' pharmaceutical API manufacturing site receives Certificate of Inspection from ...



Sai Life Sciences' pharmaceutical API manufacturing site receives Certificate of Inspection from PMDA, Japan  PR Newswire

China And Japan Encourage Clinical Research By Streamlining Approval - Clinical Leader



China And Japan Encourage Clinical Research By Streamlining Approval  Clinical Leader