RESOURCE
CENTER
14Jun
Leveraging Statistical Approaches in Drug Safety Analysis
Drug safety in clinical trials is ensured through the application…
30May
Center for Clinical Trial Innovation
Medical research is progressing rapidly to keep up with the…
28May
Data Integrity for In Vivo BABE Studies
The pharmaceutical industry is evolving with technological advancements with a…
24May
Redesigned Pre-Submission Meetings for ANDAs with the US FDA
Pre ANDA meetings facilitate pre-submission communications with the US FDA…
21May
Electronic Submissions for Investigational New Drug Safety Reports
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Oprócz bezpieczeństwa i uczciwości, legalne kasyna online oferują także atrakcyjne promocje i bonusy. Mogą to być bonusy powitalne, darmowe spiny czy regularne turnieje, które dodatkowo zwiększają szanse na wygraną. Wszystko to sprawia, że gra w legalnym kasynie to doskonała forma rozrywki, a jednocześnie pewność, że gra odbywa się w bezpiecznym środowisku.
Regulatory agencies like the United States’ FDA are increasingly encouraging…
14May
A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products
Imagine a world where medical care is not just about…
13May
Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products
Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products,…
08May
Pharmacovigilance in New Zealand
Medsafe oversees pharmaceutical product regulation in New Zealand and operates…
07May
Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products
Early-phase clinical trials for cell and gene therapy (CGT) products…
02May
Navigating Orphan Drug Regulations for Gene Therapy Products
Human gene therapy products, like other medicines, may be eligible…
29Apr
DDReg Features in BioPharma Dive: At the Forefront of Biotech and Pharma
Join DDReg at the Biotech Beach of the world! Meet…
24Apr
Conducting Clinical Trials for Investigational Products in Brazil
Brazil is emerging as an attractive location for clinical research…
22Apr
Controlled Correspondence for Generic Drug Development
Regulatory agencies across the globe are committed to ensuring that…
18Apr
CMC Considerations for Human Gene Therapy INDs
Human gene therapy represents a groundbreaking frontier in medicinal products…
17Apr
Commitment to Biological Product and Patient Safety in India
Biological products are derived from living organisms or cells encompass…
15Apr
Empowering Rare Disease Drug Developers
Advanced rare disease drug developers are companies or organizations that…
09Apr
DDReg Opens Entity in Singapore
The Association of Southeast Asian Nations (ASEAN) region presents an…
08Apr
How is Team AB Gearing up for the new MedTech Legislation?
In the development of the UK’s medical device industry, a…
01Apr
Harmonization for the Development of Cell and Gene Therapies
In the emerging boom of biopharmaceuticals, the remarkable advancements in…
28Mar
Essential Aspects of Labeling for Clinical Supplies and Investigational Products
With the expansion of clinical research and development, precise labeling…
26Mar
Assessing COVID-19 Symptoms in Clinical Trials
The onset of the coronavirus, or COVID-19, created havoc across…
20Mar
Asserting Patient Rights: The Importance of Labels for Medical Device Traceability
In the realm of healthcare, patients have a fundamental right…
18Mar
Importance of Collaboration between Global Regulators
Regulatory authorities across the globe play a pivotal role in…
14Mar
DDReg Opens German Entity in Cologne (Köln)
DDReg is thrilled to announce a significant milestone that is…
13Mar
Submitting Revised ANDA Labels to Ensure Safety & Compliance
Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a…
04Mar
Development of CAR T Cell Products
Chimeric antigen receptor (CAR) T cell products refer to therapeutic…
27Feb
Model-Integrated Evidence Program for Generic Drugs
Timely patient access to affordable treatment options is the goal…
22Feb
Searchable Databases for Bio-Equivalence Guidance
Product-specific bioequivalence guidelines are crucial to support the development of…
19Feb
The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products
The field of gene therapy has witnessed significant advancements with…
14Feb
Increasing Harmonization for Complex Generics
Regulatory agencies across the globe are increasing their efforts in…
12Feb
Strengthening Safety Compliance in Somalia
The National Medicine Regulatory Authority (NMRA) of the Ministry of…
08Feb
Ensuring Viral Safety of Biotechnology Products
Biotechnology products that are derived from cell lines are associated…
05Feb
Regulatory Roadmap for Access to MedTech
In an era driven by technological advancements, particularly in healthcare,…
02Feb
Fostering Medical Innovation with Expedited Review Processes
2023 marked a significant year in the pharmaceutical industry as…
29Jan
Easing Requirements for Minimal Risk Clinical Trials
Expediting clinical trials that post minimal risk is important to…
25Jan
Standardizing Real World Data for Drug and Biological Product Submissions
Real world data (RWD) is proving to be an important…
23Jan
Streamlining Clinical Investigations for Medical Devices
Clinical investigations for medicinal devices are critical in order to…
22Jan
DDReg Managing Director wins ET RE Pharma “Woman Icon of the Year” Award 2024
The 4th edition of the Economic Times (ET) RE Pharma…
18Jan
Third Party Review Program for Medical Devices
The onset of the pandemic highlighted many obstacles pertaining to…
15Jan
SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products
Efficiently detecting safety signals for veterinary products is crucial for…
11Jan
Effective Communication for the Safe Use of Biosimilars
Biosimilars and interchangeability with biologics has been a topic of…
08Jan
Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid
Pharmacovigilance in India has come a long way over the…
05Jan
The Use of Item Response Theory in Clinical Outcome Assessments
Clinical outcome assessments (COAs) are a critical component of clinical…
03Jan
Enhancing Medical Device Cybersecurity
The integration of wireless, Internet, and network-connected capabilities in medical…
02Jan
Utilizing Real-World Evidence for Medical Devices
Recent years have witnessed a surge in clinical practice data…
27Dec
Quality Assurance and Compliance
Ensuring that products and services meet the highest standards of…
21Dec
Reforming ANDA Suitability Petitions
Pharmaceutical companies have faced delays in receiving a response to…
19Dec
Online Eligibility Checker Tool for International Recognition Procedure
The International Recognition Procedure (IRP), initiated by the Medicines and…
15Dec
DDReg participates in the DIA-US FDA-ANDA workshop
Regulatory policies that govern generic drug applications, like the Abbreviated…
15Dec
UK MHRA: Navigating Nuances in Clinical Trial Applications
The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives…
12Dec
Fostering bilateral trade and harmonized efforts in medicine regulation
The importance of aligning pharmaceutical regulations in the development process…
07Dec
ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices
The medical device sector in Argentina and Brazil is experiencing…
04Dec
Advancing Healthcare through Electronic Product Information
Electronic Product Information (ePI) is authorized, statutory information for medicines,…
30Nov
DDReg Participates in India Pharma Awards 2023 for Excellence in Ancillary Pharma Services
DDReg participated in the 10th edition of the prestigious India…
28Nov
How is EMA Addressing Medicine Shortages in Europe?
The emergence of drug shortages as a significant global health…
22Nov
Kenya’s Systematic Approach to Pharmacovigilance
Pharmacovigilance (PV) and drug safety surveillance activities rely on a…
20Nov
MHRA’s AI-Airlock for Safe Development of Medical Technologies
The use of artificial intelligence (AI) in the Pharmaceutical and…
17Nov
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
As more artificial intelligence (AI) and machine learning (ML) technologies…
16Nov
ISoP: The Need for Patient Engagement in Pharmacovigilance
Pharmacovigilance is paramount for the well-being of patients exposed to…
09Nov
DDReg’s Diwali Celebration 2023
Diwali is a time filled with happiness, togetherness, and festivities-…
07Nov
AMDF: Ensuring the Safety of Donated Medical Devices
In times of emergencies like war, disease outbreak, natural disasters…
06Nov
DDReg attends the OTC Health and Wellness Conference 2023
The OTC Health and Wellness Conference was held on the…
02Nov
Japan PMDA: The Role of In-Country Clinical Caretakers
Japan has a robust regulatory framework for pharmaceuticals and medical…
31Oct
Regulatory Framework for Cosmetics in South Korea
The cosmetics sector in South Korea has witnessed impressive expansion…
27Oct
Pharmacovigilance in Herbal and Alternative Medicine
At the turn of the millennium, guidelines for post-marketing safety…
27Oct
DDReg attends CPHI Barcelona
CPHI Barcelona was held on 24th to 26th of October…
21Oct
DDReg nominated for India 5000 Best MSME Awards 2023
DDReg is thrilled to announce its successful nomination for the…
19Oct
Supporting Labelling Compliance with Searchable Databases
Biopharmaceutical product labelling is a multifaceted undertaking that spans various…
17Oct
Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making
Real-World Evidence (RWE) refers to clinical evidence derived from real-world…
11Oct
Modernization of Cosmetics Regulation Act
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents…
10Oct
Ensuring Safe Use of Medical Devices in Healthcare Facilities
The safe and effective use of medical devices in healthcare…
04Oct
Evaluating the need for comparative clinical efficacy studies in biosimilar development
Introduction Long-term safety, efficacy, and immunogenicity data of licensed biosimilars…
03Oct
Prescription-Drug-Use-Related Software
Introduction With the advancement in digital technology, the development of…
29Sep
DDReg Shortlisted for ‘Regulatory’ by CPHI Pharma Awards 2023
DDReg is thrilled to announce that it has made it…
28Sep
Requesting Post-Warning Letter Meetings
During an inspection, the US FDA may detect that the…
26Sep
Navigating Drug Manufacturing Inspections
The US FDA conducts drug manufacturing inspections for facilities to…
21Sep
DDREG & OKTANE HR – Training and Development Program for Employees
DDReg took a significant stride toward nurturing its team’s potential…
20Sep
UK MHRA International Recognition Procedure
The UK MHRA’s Latest Update on the International Recognition Procedure…
18Sep
How does EMA use Artificial Intelligence and Large Language Models in Medicine Regulation?
Artificial Intelligence in Medicine Regulation– a perspective by Emer Cooke,…
14Sep
Formal Meetings for Biosimilar Product Development with the US FDA
Comprehending the Key Components of Formal Meetings for Biosimilar Development…
12Sep
Paediatric Investigation Plan in Medicinal Product Development
Navigating the Paediatric Investigation Plan and its Significance in the…
05Sep
Packaging Requirements for the Safety of Children
Saudi Food and Drug Authority’s Requirements on Child-Resistant Packaging for…
01Sep
Post-market safety data for underrepresented populations in clinical trials
Introduction Regulatory agencies require sponsors to collect and provide data…
29Aug
How to prepare for oral explanations with EMA
A marketing authorisation application (MAA) can take up to 210…
24Aug
Guidance on Informed Consent in Clinical Investigations
Within the realm of clinical research, the process of obtaining…
22Aug
Diversity Plan in Clinical Trials
The importance of recruiting diverse patients for clinical trials in…
17Aug
US FDA: Enhancing the safety of cosmetic products
In the ever-evolving landscape of personal care and aesthetics, cosmetic…
14Aug
Overcoming challenges in determining AI limits for NDSRIs
Introduction Nitrosamine Drug Substance-Related Impurities (NDSRIs) share structural similarity with…
10Aug
Mandating CADIFA for drug registration in Brazil
Navigating through API requirements to successfully register a drug product…
04Aug
CDER: Creating efficiencies in pharmaceutical development and manufacturing
The Center for Drug Evaluation and Research (CDER) of the…
28Jul
The Impact of Artificial Intelligence in the Lifecycle of Medicines
The rapid digitalization of the biomedical and clinical research sectors…
25Jul
Enhancing Accessibility to Contraceptives through Rx-to-OTC switch
In a world where women’s health and autonomy are of…
18Jul
The Future of Certificate of Suitability
The Certificate of Suitability (CEP) to the monographs of the…
14Jul
ICH: An Approach to Harmonizing Real World Data & Real World Evidence
The use of real-world data (RWD) and real-world evidence (RWE)…
11Jul
US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs
Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of…
07Jul
DDReg Exhibits at DIA Global 2023
The DIA Global Annual Meeting in 2023, which took place…
05Jul
US FDA: Safety Reporting Requirements for Combination Products
In this new era, where different therapeutic realms converge, the…
20Jun
Challenges in Complex Generic Drug Development
Complex drugs add more value to patients compared to simple…
16Jun
US FDA: Keeping Up with the Momentum of Decentralized Clinical Trials
Decentralized clinical trials (DCTs) are evolving and gaining momentum within…
14Jun
Evaluating PRIME: A Pathway for Innovative Medicines
In various therapeutic areas where life expectancy is low, delayed…