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    Category Articles: Health


    (Published: Mon, 08 Aug 2022 15:29:47 +0000)
    Labeling Requirements for California's Cleaning Products
    Cleaning product labels are no different than labels for other consumer goods when disclosure of ingredients comes into play. Organizations should exercise safety practices that will protect the consumers and workers during consumption.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 08 Aug 2022 15:26:52 +0000)
    Overview on Electronic Product Information ePI Labeling
    In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 08 Aug 2022 15:26:10 +0000)
    An Overview on Quality Review of Document QRD
    This article talks about the overview on Quality Review of Document (QRD) of medicines in Europe To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 04 Aug 2022 14:06:58 +0000)
    South Koreas MFDS regulations on AI-based Medical Devices
    The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practiti
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 04 Aug 2022 14:06:05 +0000)
    Role of Marketing Authorization Holder MAH for medical device registration in Japan
    Globally, the Health Agencies require foreign medical devices and IVD manufacturers to appoint a local representative. In Japan, under the revised Pharmaceuticals and Medical Device (PMD) Act, the In-Country Caretaker (ICC) system was replaced with Marketing Authorization Holder (MAH) system. Under
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 25 Jul 2022 15:28:59 +0000)
    Key requirements for Pharmaceutical Serialization
    With serialization legislation introduced in two (02) major drug markets, namely, the USA and the EU, the pharma industry is being forced to take action on a large scale. On the other side, people are slowly realizing the benefits that serialization could bring in terms of patient safety and supply
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 25 Jul 2022 15:28:18 +0000)
    Evolving with Pharmaceutical Serialisation, Tracking and Tracing
    "In-depth analyses will highlight how pharmaceutical packaging, labeling, serialization, tracking, and traceability enhance consumer safety and transparency in the supply chain, as well as benefit pharmaceutical packaging that go beyond compliance with laws. As the pharmaceutical industry continu
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 30 Jun 2022 07:15:08 +0000)
    Regulatory Intelligence RI: The Focal Point of Your Business
    This article talks about the importance of integrating Regulatory Intelligence (RI) Solutions with your Business to overcome the current challenges in the industry.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 30 Jun 2022 07:14:09 +0000)
    EMAs Perspective on the Future of Medicines Regulations
    This article talks about the EMA’s perspective on the future of medicines regulations. The prime goal of a Health Authority (HA) is to promote and protect the interests of those it serves by amending and introducing new regulations. The European Medicines Regulatory Network (EMRN) is a network of
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 30 Jun 2022 07:13:15 +0000)
    Steps for the pharmaceutical organizations for successful regulatory submissions
    This article talks about the measures that pharmaceutical organizations must take for successful regulatory submissions.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 30 Jun 2022 07:12:43 +0000)
    EMA's Pharmacovigilance Activities to identify an alert signal
    This article talks about the trigger for EMA's Pharmacovigilance Activities to identify an alert signal.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 30 Jun 2022 07:12:03 +0000)
    South Koreas UDI Compliance Requirements for Medical Device Registrations
    This article talks about the South Korea’s UDI compliance requirements for Medical Device registrations.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 20 Jun 2022 05:25:34 +0000)
    Quality by Design QbD- An Enhanced Route for Drug Development
    Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework. From Active Pharmaceutical Ingredient (API) identification to its placement on the patient’s side table, the core of innovating novel treatment protocols revolves around thre
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 20 Jun 2022 05:24:49 +0000)
    Optimizing Regulatory Submissions with Structured Content and Data Management SCDM
    Pharmaceutical companies incur about 25% of drug development costs into the documentation. Strategic imperatives can help accelerate the drug development pipeline along with scrutiny of clinical and Regulatory content, enabling efficient reuse of more standardized content. Identifying gaps associate
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 07 Jun 2022 10:10:16 +0000)
    Top 15 Frequently Asked Questions FAQs on US Agent
    The US is the largest medical device market, worth USD 180 billion (2021) and is expected to reach USD 670 billion at a CAGR of 5.2% from 2022 to 2027. The global medical device manufacturers find it promising to get their devices approved by US FDA and subsequently export them to the US.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 07 Jun 2022 10:09:41 +0000)
    Comparative Analysis of Dossier Submissions in Europe EU& United States US Market
    Over the past ten (10) years, the cost of bringing a drug into the market has increased by 140 percent. Globally, the top twenty (20) pharmaceutical organizations spend nearly sixty (60) billion dollars every year to bring a drug into the market and the average cost is estimated to be $2.6 billion,
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 12 May 2022 15:27:57 +0000)
    An Exclusive Webinar on Medical Devices in the UK & UKCA Certification Readiness
    Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on Jan
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Fri, 06 May 2022 09:58:49 +0000)
    Modernization of Food Regulations in Canada
    This article talks about the Modernization of Health Canada’s Food Regulations to ensure safety and smooth market entry of products in Canada.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Fri, 06 May 2022 09:57:53 +0000)
    Health Canada Labeling standards for Cosmetic products in Canada
    This article talks about the Health Canada’s (HC) cosmetic labeling regulations and the importance of International Nomenclature of Cosmetic Ingredients (INCI) in Canada.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Fri, 06 May 2022 09:57:09 +0000)
    Regulatory Publishing & Submission with Automation
    This article talks about the transformation of regulatory publishing & submissions with automation to reduce the time and improve productivity.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:45:17 +0000)
    Data-driven Regulatory Intelligence System for Life science Companies
    This article talks about the data-driven regulatory intelligence system for Life science companies to stay compliant with the new global Health Authority regulatory guidelines.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:44:47 +0000)
    FSSAIs New Labeling & Display Regulations for Pre-packed Foods
    This article talks about the FSSAI’s new labeling & display regulations for pre-packed foods.The Food Safety and Standards Authority of India (FSSAI) has divided the ‘Food Safety and Standards (Packaging and Labeling) Regulations, 2011’ into two (02) separate regulations: Food Safety and S
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:43:45 +0000)
    US FDA's cost-saving approach to the transition from CSV to CSA in 2022
    This article talks about the US FDA's cost-saving approach to the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA) in 2022.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:06:11 +0000)
    HPRAs Perspective on multilingual labeling
    This article talks about the Health Products Regulatory Authority's (HPRA) Perspective on Multilingual Labeling.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Wed, 20 Apr 2022 12:05:40 +0000)
    PAAB Complements the Standard Preclearance Pathway with Accelerated Review Options AROs
    This article talks about the PAAB (Pharmaceutical Advertising Advisory Board) Complement on the Standard Pre-clearance Pathway with Accelerated Review Options (AROs).
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:15:26 +0000)
    EMA Initiates DARWIN EU for RWE Integration in Medicines Assessment
    On February 09, 2022, the European Medicines Agency (EMA) commenced the establishment of a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®). It is the first step towards integrating Real-World Evidence (RWE) into assessing medicines across the European Union (EU
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:14:32 +0000)
    Regulatory Overview on Sunscreens in Australia
    Sunscreen is an important component of an effective sun protection regime. They must be safe, effective, and of good quality. For this reason, the TGA regulates sunscreens as therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARG
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:13:56 +0000)
    An Overview on Therapeutic Products Regulation in New Zealand
    Medsafe, aka the New Zealand Medicines and Medical Devices Safety Authority, undertakes the regulation of therapeutic products in New Zealand. The Agency is a business unit of the Ministry of Health. It follows several legislations for regulating therapeutic products, the major ones being the Medici
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:13:06 +0000)
    EMRN Adopts a Common ePI Standard for Medicines in the EU
    The European Medicines Regulatory Network (EMRN) has adopted a common electronic Product Information (ePI) standard for human medicines. The common ePI standard was one of the major projects undertaken by the European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:12:10 +0000)
    EU Notified Bodies NBs Proposed Solutions for MDR & IVDR Implementation Challenges
    The European Notified Bodies (NBs) have published a new position paper to address the concerns of MDR/IVDR designated NBs. It will be effective from May 26, 2022 to May 26, 2024. The MDR/IVDR regulations aim to improve patient safety by strengthening the requirements for manufacturers and NBs.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:11:36 +0000)
    Food Standards Australia New Zealand's FSANZ labeling standards for food products
    As you may know, every country has its own set of regulations when it comes to labeling food products. Food labeling is a legal requirement and provides a wide range of information to help consumers make informed food choices. It protects public health and safety by displaying ingredients, use-by da
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:11:03 +0000)
    FDA published a series of updated guidance documents
    Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 15:10:28 +0000)
    Responsible Person RP, A Fundamental Requirement of the Cosmetic Industry
    To ensure that cosmetics align with the latest quality and safety standards, markets across the globe have stringent Regulatory requirements. In markets such as the European Union, the United Kingdom, Malaysia, India, Saudi Arabia, etc., appointing a Legal Representative/Responsible Person (RP)/ Loc
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:50:56 +0000)
    US FDA Final Guidance on Population Pharmacokinetics
    After nearly two (02) decades of issuing the first draft guidance, the United States Food and Drug Administration (US FDA) finalized the guidance on population Pharmacokinetics (PK) in February 2022. The latest draft explains the application of population PK in drug development and recommendations o
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:50:17 +0000)
    USFDAs Emergency Use Authorizations
    Emergency Use Authorizations (EUAs) are significant in making life-saving medicinal products available to patients faster. They have been helpful in dealing with pandemics like COVID-19. An initiative of the United States Food and Drug Administration (USFDA) started in the year 2004, and the EUA cam
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:49:40 +0000)
    EU Announces Clinical Trials Transformative Initiative
    Currently, the European clinical trials environment is quite challenging. The COVID-19 pandemic has shown a relative absence of EU impactful, multi-state trials. In addition, the disharmony of Regulatory requirements between the Member States has complicated the submission of multi-state trial appli
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Mon, 04 Apr 2022 14:49:01 +0000)
    WHO Considerations for Regulating Cell and Gene Therapy Products CGTPs
    To promote global convergence among the Health Authorities and encourage the Member States to strengthen their Regulatory system on Cell and Gene Therapy products regulations, the WHO (World Health Organization) proposed a risk-based framework for regulating Cell and Gene Therapy Products (CGTPs). T
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 15 Mar 2022 13:48:24 +0000)
    DADI, An Upcoming Regulatory Business Transformation Project from the EMA
    This article talks about the EMA designed Digital Application Dataset Integration (DADI) project acts as replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions. In addition to completing the requisite xEVMPD data submissions, life sciences or
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 03 Mar 2022 13:00:11 +0000)
    Pharmaceutical Labels and Errors to Avoid
    A pharmaceutical label is a monologue between the drug manufacturer and the patients. Miscommunication of any kind can affect the end-user. To protect the interest of the patient population, global Health Authorities (HAs) closely monitor pharmaceutical labels and indications of pre-approval. There
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:47:07 +0000)
    Regulation for Hair Colorants in the EU
    Hair colorants are classified as cosmetic products by the European Commission (EC) and are regulated under the regulation (EC) No: 1223/2009. Hair colorants contain a mixture of substances called hair dyes that are used to change the color of hair or to restore the original hair color.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:46:31 +0000)
    Key Highlights from FSSAI Published Front Pack of Labelling FOPL Update
    FSSAI published a major update on the Front Pack of Labelling (FOPL) on 22nd February 2022 after a meeting with the stakeholders, to decide the remaining issues related to ‘Front of Pack Labelling’ under the Chairmanship of CEO, FSSAI. The FSSAI commenced the meeting with a presentation on the d
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:44:15 +0000)
    ECs Electronic-IFU eIFU rules for medical devices
    Medical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU).
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:43:40 +0000)
    SPC Exception is a Boon for Generics and Biosimilars Manufacturers in the EU Market
    While innovators or branded drug products carry additional costs associated with the research and development of the product from the molecule identification stage to post-market authorization, generic drug products are relatively cost-effective. These therapies not only reduce the overall cost of t
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:42:42 +0000)
    Health Canadas Preferred ANDS Gateway for Generic Drugs
    Canada ranks ninth in the world in value for generic drugs and has reached $5.8bn in sales as of today in 2022. To make effective, safe, and affordable drugs readily available to patients in the country, Health Canada – Canada’s Health Authority, is taking initiatives to improve the accessibilit
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Tue, 01 Mar 2022 11:42:04 +0000)
    MHRAs Novel Approach for Enhanced Accessibility of Innovative Drugs in UK
    To enhance the accessibility of innovative medicines for patients in the UK post-Brexit, a new and accelerated approval pathway is known as the Innovative Licensing and Access Pathway (ILAP) was launched in January 2021. Its primary objective was to provide an integrated roadmap for all the stakehol
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:33:18 +0000)
    Comparative Analysis of TGAs 2018 and 2021 Advertising Codes
    To educate patients and Health Care Professionals (HCPs) and promote treatment options, the pharmaceutical industry like many other industries dedicates billions of dollars to advertise and promote prescription drugs. The legislative framework of advertising in Australia comes under Section 42BAA of
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:32:27 +0000)
    Obligations of Economic Operators EOs under the Swissmedics MedDO
    There are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs. The three (
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:31:32 +0000)
    FDAs Alternative Methods to Reduce Nitrosamine Impurity Levels in Drugs
    This article talks about the FDA’s alternative methods to reduce Nitrosamine Impurity levels in drug products.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:30:54 +0000)
    EC Plans to prevent Disruption of Medicines Supply Post-Brexit for Northern Ireland
    Based on the European Commission’s (EC) proposal on facilitating the movement of goods from Great Britain to Northern Ireland in October 2021, the Commission has now set up plans to maintain the medicines’ supply in specific markets post-Brexit.
    Author: Freyr Solutions Inc
    Directory: Health
    (Published: Thu, 24 Feb 2022 09:30:11 +0000)
    EMAs Initiative for Regulatory Science Research Needs
    To note, there are many gaps in the Regulatory science that need to be addressed for the development and evaluation of medicine. Global Regulatory Agencies make strong efforts to close these gaps and enable access to innovative medicines that address the patient’s needs.
    Author: Freyr Solutions Inc
    Directory: Health

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