"PMDA" の関連情報検索結果

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

Expediting Drug Development in Japan: A PMDA Perspective - Wiley



Expediting Drug Development in Japan: A PMDA Perspective  Wiley

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

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



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

MIDD in Japan– Implementations, challenges and opportunities - ScienceDirect.com



MIDD in Japan– Implementations, challenges and opportunities  ScienceDirect.com

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

Kinetic Analysis of PMDA-Induced Chain Extension in Polyester Blends: Differential Reactivity of ...



Kinetic Analysis of PMDA-Induced Chain Extension in Polyester Blends: Differential Reactivity of rPET and PBT during Reactive Extrusion  ACS Publications

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

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



Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec  FinancialContent

Clinical data required for the approval of pediatric pharmaceuticals in Japan - BMC Pediatrics



Clinical data required for the approval of pediatric pharmaceuticals in Japan  BMC Pediatrics

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

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

Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec - The Joplin G...



Ferring Japan announces PMDA Acceptance of NDA Filing for nadofaragene firadenovec  The Joplin Globe

Legacy Healthcare Receives Positive Feedback from Japan's Health Authority (PMDA) on Regulatory P...



Legacy Healthcare Receives Positive Feedback from Japan's Health Authority (PMDA) on Regulatory Pathway and Phase 3 Clinical Program for Cinainu in Japanese Children, Adolescents and Adults with Moderate to Severe Alopecia Areata (AA)  PR Newswire

Japan PMDA opens second overseas office in Washington - BioWorld MedTech



Japan PMDA opens second overseas office in Washington  BioWorld MedTech

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: 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

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

BioCardia Submits CardiAMP Therapy for PMDA Review - TipRanks



BioCardia Submits CardiAMP Therapy for PMDA Review  TipRanks

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

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



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

Poxel Announces Regulatory Approval by Japanese Authorities to Expand TWYMEEG - Business Wire



Poxel Announces Regulatory Approval by Japanese Authorities to Expand TWYMEEG  Business Wire

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)

Two decades of new drug approvals in Japan - Nature



Two decades of new drug approvals in Japan  Nature

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



WuXi Biologics Successfully Passes Japan PMDA GMP Inspection Again  BioSpectrum Asia

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



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

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

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



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

PMDA’s proactive action to ensure quick drainage of rainwater in Panchkula city - The Impressive ...



PMDA’s proactive action to ensure quick drainage of rainwater in Panchkula city  The Impressive Times

Pursuing cell therapy approvals in APAC: your guide to navigating regulations in Japan, South Kor...



Pursuing cell therapy approvals in APAC: your guide to navigating regulations in Japan, South Korea, and Singapore  ScienceDirect.com

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

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

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

PMDA CEO K. Makarand Pandurang conducts surprise inspection of Panchkula city - The Impressive Times



PMDA CEO K. Makarand Pandurang conducts surprise inspection of Panchkula city  The Impressive Times

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

Ami Organics' Unit II receives Japan PMDA nod for GMP compliance - Capital Market



Ami Organics' Unit II receives Japan PMDA nod for GMP compliance  Capital Market

Haryana right to service commission mulls penalty on MC, PMDA officers for delay in road repair -...



Haryana right to service commission mulls penalty on MC, PMDA officers for delay in road repair  The Times of India

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

Japan Recommends Approval Of Brukinza, Balversa - insights.citeline.com



Japan Recommends Approval Of Brukinza, Balversa  insights.citeline.com

Biosimilars approved in Japan - Generics and Biosimilars Initiative



Biosimilars approved in Japan  Generics and Biosimilars Initiative

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

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

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

Eyes on every street: Panchkula to launch AI-powered city control centre - Hindustan Times



Eyes on every street: Panchkula to launch AI-powered city control centre  Hindustan Times

Insights into post-marketing clinical validation of companion diagnostics with reference to the F...



Insights into post-marketing clinical validation of companion diagnostics with reference to the FDA, EMA, PMDA, and MFDS  ScienceDirect.com

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

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

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

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

Structure to properties relations of BPDA and PMDA backbone hybrid diamine polyimide aerogels - S...



Structure to properties relations of BPDA and PMDA backbone hybrid diamine polyimide aerogels  ScienceDirect.com

High-resolution microscopy of PMDA-ODA polyimide single crystals - ACS Publications



High-resolution microscopy of PMDA-ODA polyimide single crystals  ACS Publications

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



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

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



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

Condensation reaction scheme between PMDA and DAB precursors to deposit pyrrone film. - researchg...



Condensation reaction scheme between PMDA and DAB precursors to deposit pyrrone film.  researchgate.net

Preparation of GO/Fe3O4@PMDA/AuNPs nanocomposite for simultaneous determination of As3+ and Cu2+ ...



Preparation of GO/Fe3O4@PMDA/AuNPs nanocomposite for simultaneous determination of As3+ and Cu2+ by stripping voltammetry  ScienceDirect.com

Japan keen to deepen regional partnerships, says PMDA head - BioWorld MedTech



Japan keen to deepen regional partnerships, says PMDA head  BioWorld MedTech

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

Japan’s health regulator MHLW approves five new medications - World Pharmaceutical Frontiers



Japan’s health regulator MHLW approves five new medications  World Pharmaceutical Frontiers

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



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

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



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

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

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

PMDA giving new momentum to urban development in Panchkula: CEO Pandurang - Press Trust of India



PMDA giving new momentum to urban development in Panchkula: CEO Pandurang  Press Trust of India

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



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

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

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

Fig. 1 Structure of PMDA/ ODA-based polyamic acid - researchgate.net



Fig. 1 Structure of PMDA/ ODA-based polyamic acid  researchgate.net

CDER Works with Global Regulators on Drug Assessments and Inspections - fda.gov



CDER Works with Global Regulators on Drug Assessments and Inspections  fda.gov

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



Biocon Biologics Secures Japan PMDA Approval For Psoriasis Drug  IPO Central

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

Achievements and challenges of the Sakigake designation system in Japan - British Pharmacological...



Achievements and challenges of the Sakigake designation system in Japan  British Pharmacological Society | Journals

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

Figure 1. Structure of PMDA-ODA polyimide and Al (111) unit cell. - researchgate.net



Figure 1. Structure of PMDA-ODA polyimide and Al (111) unit cell.  researchgate.net

Fig. 2. (a) One of the probable crystal structures of PMDA/ODA.... - researchgate.net



Fig. 2. (a) One of the probable crystal structures of PMDA/ODA....  researchgate.net

Solid‐state NMR spectra of PMDA/pPDA polyimide and CMS materials:... - researchgate.net



Solid‐state NMR spectra of PMDA/pPDA polyimide and CMS materials:...  researchgate.net

Efficient removal of phosphate by nitrogen and oxygen-rich polyethyleneimine composite - ScienceD...



Efficient removal of phosphate by nitrogen and oxygen-rich polyethyleneimine composite  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

Global Focus: Japan’s Regenerative Medicine Regulatory Pathways: Encouraging Innovation and Patie...



Global Focus: Japan’s Regenerative Medicine Regulatory Pathways: Encouraging Innovation and Patient Access  Food and Drug Law Institute (FDLI)

Fig. 2. Steric structures of several alicyclic dianhydrides: (a) H-PMDA... - researchgate.net



Fig. 2. Steric structures of several alicyclic dianhydrides: (a) H-PMDA...  researchgate.net

Japan approves Partner’s inhaled Leukine for aPAP treatment - Pharmaceutical Technology



Japan approves Partner’s inhaled Leukine for aPAP treatment  Pharmaceutical Technology

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

FTIR spectra of PUIF prepared with different dosages of PMDA. - researchgate.net



FTIR spectra of PUIF prepared with different dosages of PMDA.  researchgate.net

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

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

Companion Diagnostics Regulations are Evolving in Asia - MedTech Intelligence



Companion Diagnostics Regulations are Evolving in Asia  MedTech Intelligence

The New ICH M12 Guideline – Harmony at Last for DDI Studies! - Evotec



The New ICH M12 Guideline – Harmony at Last for DDI Studies!  Evotec

National Cancer Center Japan and Pharmaceuticals and Medical Devices Agency Endorsed as a joint C...



National Cancer Center Japan and Pharmaceuticals and Medical Devices Agency Endorsed as a joint Center of Excellence by APEC  ncc.go.jp

a¹H spectrum of ODA-PMDA-based PAA polymer synthesized in an anhydrous... - researchgate.net



a¹H spectrum of ODA-PMDA-based PAA polymer synthesized in an anhydrous...  researchgate.net

Japanese approval for first ustekinumab biosimilar - Generics and Biosimilars Initiative



Japanese approval for first ustekinumab biosimilar  Generics and Biosimilars Initiative

Japan's PMDA reviews hep B risk link to hep C therapies - Fierce Pharma



Japan's PMDA reviews hep B risk link to hep C therapies  Fierce Pharma

Newly appointed Information Minister Marriyum Aurangzeb announces PMDA's disbanding - Dawn



Newly appointed Information Minister Marriyum Aurangzeb announces PMDA's disbanding  Dawn

PointCross Releases eDataValidator for SDTM, ADaM, SEND, and Define.XML Conformance to Prevailing...



PointCross Releases eDataValidator for SDTM, ADaM, SEND, and Define.XML Conformance to Prevailing FDA, CDISC, and PMDA Rules  Newswire.com

Scheme 1. Synthesis of PMDA-BisAPAF-HEMA poly(amic ester). - researchgate.net



Scheme 1. Synthesis of PMDA-BisAPAF-HEMA poly(amic ester).  researchgate.net

BioCardia submits Japan application for CardiAMP to treat ischemic HFrEF - Clinical Trials Arena



BioCardia submits Japan application for CardiAMP to treat ischemic HFrEF  Clinical Trials Arena

What Is The U.S.-Russia Plutonium Management And Disposition Agreement? - Radio Free Europe/Radio...



What Is The U.S.-Russia Plutonium Management And Disposition Agreement?  Radio Free Europe/Radio Liberty

Terumo Aortic announces PMDA approval and first commercial implant of Treo endovascular device in...



Terumo Aortic announces PMDA approval and first commercial implant of Treo endovascular device in Japan  Vascular News

Japan’s Drug Agency Seeks US Office with Eye on Washington to Help Japanese Obtain New Effective ...



Japan’s Drug Agency Seeks US Office with Eye on Washington to Help Japanese Obtain New Effective Treatments  The Japan News

Japan’s PMDA now offers pre-consultations for medical device registrants - MassDevice



Japan’s PMDA now offers pre-consultations for medical device registrants  MassDevice