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FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides
The rapid evolution of biotechnology has positioned oligonucleotide-based therapeutics as…
What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions
The rapid advancement of biologics and the complexity of their…
Accelerating Drug Development with Europe’s New Clinical Trial Pilots
The journey from discovering a promising compound to its approval…
What does the scenario of biosimilar cell and gene therapies look like?
Cell and gene therapy (CGT) products are gradually paving the…
Complying with Safety Reporting Requirements in the EU’s CTD to CTR Transition
Since 2004, clinical trials (CTs) in the European Union (EU)…
FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access
The U.S. Food and Drug Administration has launched the REMS…
Quantiphi, DDReg Partner to Transform Regulatory Reporting in Life Sciences Through AI
Gurgaon, INDIA – Quantiphi, a global AI-first digital engineering company…
Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14
Imagine a pharmaceutical company about to launch a new drug.…
DDReg Diwali Gala 2024
Diwali is a very special time in India, where everyone…
Understanding Post-Approval Manufacturing Changes in Biosimilars and Interchangeable Products in USA
After a biosimilar or interchangeable product gets regulatory approval by…
Updates to the Declaration of Helsinki
The Declaration of Helsinki (DoH), the first international set of…
Navigating EU Classification Standards for AI in Medical Devices and Diagnostics
The European Union (EU) has introduced stringent classification standards for…
Expediting Access to Cell and Gene Therapy Products
In the past four decades, the number of drugs being…
Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program
The medical device industry is driven by constant technological advancements…
Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU
Gene therapy is recognized as a revolutionary approach in treating…
How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals
At the DIA 2024 Global Annual Meeting in San Diego,…
Managing Director of DDReg chosen as finalist for CPhI Pharma Awards 2024
DDReg is incredibly proud to announce that our Founder and…
Japan’s Approach to eCTD V4.0
In the pursuit of global harmonization in pharmaceutical regulation, Japan…
Does the FDA need a new approval pathway?
The accelerated approval pathway is established to expedite the availability…
Regulatory Framework for Software and Artificial Intelligence as Medical Device
The convergence of healthcare with technology has led to giant…
Navigating the 505(b)(2) Approval Pathway
In the early days of drug development, pioneers had two…
Specifications for In Vitro Diagnostic Devices
In vitro diagnostic medical devices (IVD devices) are an integral…
Faster Access to Clinical Trial Information in Europe
Improving access to clinical trial information is critical in order…
The Use of EDDO to Ensure Drug Delivery Function
When it comes to ensuring the safety and effectiveness of…
Emerging Drug Safety Technology Program
Pharmacovigilance practices are associated with several challenges related to collection…
DDReg Celebrates 77th Independence Day
At DDReg, we believe in nurturing a strong company culture…
Ensuring Transparency for Machine Learning-Enabled Medical Devices
Transparency in Machine Learning-Enabled Medical Devices (MLMDs) refers to the…
Clinical Evaluation of Orphan Medical Devices
In the European Union, the Medical Device Coordination Group (MDCG)…
Safety Testing of Allogeneic Cells used in Cell Based Medical Products
Cell based medicinal products use a single source of cells…
Recommendations for the use of Animal & Human Derived Materials in Cell and Gene Therapy Products
The number of cell and gene therapies coming into the…
Accelerating Product Registration with SFDA’s Priority Review
It is important for regulatory agencies to implement priority review…
REMS Logic Model: Framework to link program design with assessment
Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in…
Impact of GenAI on Indian Healthcare
The Indian healthcare system has been traditionally plagued by challenges…
Machine Learning and Simulations for Clinical Trials
clinical trial simulation Artificial Intelligence (AI) entails the use of…
The Impact of Interactive Safety Graphics in Clinical Settings
The world of regulatory submissions is transforming where static documents…
Comprehensive Framework for Effective Clinical Trial Dialogue
The need for effective clinical trial dialogue is imperative to…
Accelerating Clinical Trials in the European Union
Accelerating Clinical Trials in the European Union (ACT EU) is…
DDReg Exhibits at the DIA Global Annual Meeting 2024
The Drug Information Association (DIA) Global Annual Meeting 2024 was…
DDReg Exhibits at the BIO International Convention 2024
The BIO International Convention in San Diego was an exciting…
Enhancing Global Drug Development through ICH M11
The development of new drugs is a complex process involving…
Leveraging Statistical Approaches in Drug Safety Analysis
Drug safety in clinical trials is ensured through the application…
Center for Clinical Trial Innovation
Medical research is progressing rapidly to keep up with the…
Data Integrity for In Vivo BABE Studies
The pharmaceutical industry is evolving with technological advancements with a…
Redesigned Pre-Submission Meetings for ANDAs with the US FDA
Pre ANDA meetings facilitate pre-submission communications with the US FDA…
Electronic Submissions for Investigational New Drug Safety Reports
Regulatory agencies like the United States’ FDA are increasingly encouraging…
A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products
Imagine a world where medical care is not just about…
Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products
Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products,…
Pharmacovigilance in New Zealand
Medsafe oversees pharmaceutical product regulation in New Zealand and operates…
Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products
Early-phase clinical trials for cell and gene therapy (CGT) products…
Navigating Orphan Drug Regulations for Gene Therapy Products
Human gene therapy products, like other medicines, may be eligible…
DDReg Features in BioPharma Dive: At the Forefront of Biotech and Pharma
Join DDReg at the Biotech Beach of the world! Meet…
Conducting Clinical Trials for Investigational Products in Brazil
Brazil is emerging as an attractive location for clinical research…
Controlled Correspondence for Generic Drug Development
Regulatory agencies across the globe are committed to ensuring that…
CMC Considerations for Human Gene Therapy INDs
Human gene therapy represents a groundbreaking frontier in medicinal products…
Commitment to Biological Product and Patient Safety in India
Biological products are derived from living organisms or cells encompass…
Empowering Rare Disease Drug Developers
Advanced rare disease drug developers are companies or organizations that…
DDReg Opens Entity in Singapore
The Association of Southeast Asian Nations (ASEAN) region presents an…
How is Team AB Gearing up for the new MedTech Legislation?
In the development of the UK’s medical device industry, a…
Harmonization for the Development of Cell and Gene Therapies
In the emerging boom of biopharmaceuticals, the remarkable advancements in…
Essential Aspects of Labeling for Clinical Supplies and Investigational Products
With the expansion of clinical research and development, precise labeling…
Assessing COVID-19 Symptoms in Clinical Trials
The onset of the coronavirus, or COVID-19, created havoc across…
Asserting Patient Rights: The Importance of Labels for Medical Device Traceability
In the realm of healthcare, patients have a fundamental right…
Importance of Collaboration between Global Regulators
Regulatory authorities across the globe play a pivotal role in…
DDReg Opens German Entity in Cologne (Köln)
DDReg is thrilled to announce a significant milestone that is…
Submitting Revised ANDA Labels to Ensure Safety & Compliance
Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a…
Development of CAR T Cell Products
Chimeric antigen receptor (CAR) T cell products refer to therapeutic…
Model-Integrated Evidence Program for Generic Drugs
Timely patient access to affordable treatment options is the goal…
Searchable Databases for Bio-Equivalence Guidance
Product-specific bioequivalence guidelines are crucial to support the development of…
The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products
The field of gene therapy has witnessed significant advancements with…
Increasing Harmonization for Complex Generics
Regulatory agencies across the globe are increasing their efforts in…
Strengthening Safety Compliance in Somalia
The National Medicine Regulatory Authority (NMRA) of the Ministry of…
Ensuring Viral Safety of Biotechnology Products
Biotechnology products that are derived from cell lines are associated…
Regulatory Roadmap for Access to MedTech
In an era driven by technological advancements, particularly in healthcare,…
Fostering Medical Innovation with Expedited Review Processes
2023 marked a significant year in the pharmaceutical industry as…
Easing Requirements for Minimal Risk Clinical Trials
Expediting clinical trials that post minimal risk is important to…
Standardizing Real World Data for Drug and Biological Product Submissions
Real world data (RWD) is proving to be an important…
Streamlining Clinical Investigations for Medical Devices
Clinical investigations for medicinal devices are critical in order to…
DDReg Managing Director wins ET RE Pharma “Woman Icon of the Year” Award 2024
The 4th edition of the Economic Times (ET) RE Pharma…
Third Party Review Program for Medical Devices
The onset of the pandemic highlighted many obstacles pertaining to…
SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products
Efficiently detecting safety signals for veterinary products is crucial for…
Effective Communication for the Safe Use of Biosimilars
Biosimilars and interchangeability with biologics has been a topic of…
Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid
Pharmacovigilance in India has come a long way over the…
The Use of Item Response Theory in Clinical Outcome Assessments
Clinical outcome assessments (COAs) are a critical component of clinical…
Enhancing Medical Device Cybersecurity
The integration of wireless, Internet, and network-connected capabilities in medical…
Utilizing Real-World Evidence for Medical Devices
Recent years have witnessed a surge in clinical practice data…
Quality Assurance and Compliance
Ensuring that products and services meet the highest standards of…
Reforming ANDA Suitability Petitions
Pharmaceutical companies have faced delays in receiving a response to…
Online Eligibility Checker Tool for International Recognition Procedure
The International Recognition Procedure (IRP), initiated by the Medicines and…
DDReg participates in the DIA-US FDA-ANDA workshop
Regulatory policies that govern generic drug applications, like the Abbreviated…
UK MHRA: Navigating Nuances in Clinical Trial Applications
The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives…
Fostering bilateral trade and harmonized efforts in medicine regulation
The importance of aligning pharmaceutical regulations in the development process…
ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices
The medical device sector in Argentina and Brazil is experiencing…
Advancing Healthcare through Electronic Product Information
Electronic Product Information (ePI) is authorized, statutory information for medicines,…
DDReg Participates in India Pharma Awards 2023 for Excellence in Ancillary Pharma Services
DDReg participated in the 10th edition of the prestigious India…
How is EMA Addressing Medicine Shortages in Europe?
The emergence of drug shortages as a significant global health…
Kenya’s Systematic Approach to Pharmacovigilance
Pharmacovigilance (PV) and drug safety surveillance activities rely on a…
MHRA’s AI-Airlock for Safe Development of Medical Technologies
The use of artificial intelligence (AI) in the Pharmaceutical and…
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
As more artificial intelligence (AI) and machine learning (ML) technologies…
ISoP: The Need for Patient Engagement in Pharmacovigilance
Pharmacovigilance is paramount for the well-being of patients exposed to…
DDReg’s Diwali Celebration 2023
Diwali is a time filled with happiness, togetherness, and festivities-…
