Title 21 of the Code of Federal Regulations

Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achieve RYONCIL Approval

Retrieved on: 
Thursday, September 21, 2023
MESO, BM, Partnership, EAP, GVHD, Blood, Code, Marketing, Expanded access, Survival, CFR, Title 21 of the Code of Federal Regulations, Type, Patient, Steroid, Prochymal, MSB, FDA, Transplant, Inflammation, Dietary supplement, Pharmaceutical industry, Mesoblast

FDA clarified that the key remaining issue for pediatric approval is providing further evidence that the potency assay will assure the consistent efficacy of commercial product.

Key Points: 
  • FDA clarified that the key remaining issue for pediatric approval is providing further evidence that the potency assay will assure the consistent efficacy of commercial product.
  • The key outcomes of the meeting and Mesoblast next steps are:
    Mesoblast summarised the large body of existing clinical data with the improved RYONCIL® product version of remestemcel-L, manufactured after 2008 using the current process inspected by FDA, for potential approval in children.
  • Mesoblast presented clinical data indicating that RYONCIL was associated with much higher survival of children with SR-aGVHD in the Expanded Access Protocol (EAP) compared with the earlier Prochymal version manufactured before 2008.
  • Mesoblast expects to receive the formal minutes of the Type A meeting within three weeks.

Vial Announces Strategic Partnership to Build CFR Part 11 Open Source e-Signature Platform with Documenso

Retrieved on: 
Thursday, August 24, 2023
COSS, Conceptual model, Partnership, Code, Biotechnology, DocuSign, CFR, Title 21 of the Code of Federal Regulations, Disease, Patient, SAN, Title 21 CFR Part 11, Entrepreneurship, Longevity, FDA, Medical device, Vial

In an era where digital transformation is reshaping industries, Vial's partnership with Documenso is set to drive innovation in electronic document management, particularly in meeting the rigorous requirements of CFR Part 11 compliance.

Key Points: 
  • In an era where digital transformation is reshaping industries, Vial's partnership with Documenso is set to drive innovation in electronic document management, particularly in meeting the rigorous requirements of CFR Part 11 compliance.
  • CFR Part 11 is a section of the Code of Federal Regulations (Title 21) established by the FDA.
  • Our partnership with Documenso signifies an exciting leap towards innovation by addressing a critical need in the life science sector.
  • We're excited to work alongside Vial in this endeavor, leveraging the power of Commercial Open Source (COSS) principles to provide a robust alternative to traditional solutions."

Antacids Global Market Report 2023

Retrieved on: 
Monday, February 20, 2023
Proton, Bayer, American College of Gastroenterology, Stomach, Organization, Pharmacy, Code, Title 21 of the Code of Federal Regulations, Sleep, Pfizer, Abbott Laboratories, CFR, AstraZeneca, Heartburn, Constipation, Enzyme inhibitor, Wickham Laboratories Ltd, Acid, Hypophosphatemia, Gastroesophageal reflux disease, Geography, Takeda Pharmaceutical Company, Aluminium, Mouth, GSK plc, Herbal, Esophagitis, Absorption, Milk-alkali syndrome, FDA, Antacid, Growth, Hydrogen potassium ATPase, American College, Prevalence, COVID-19, Osteomalacia, OTC, Pharmaceutical industry, Distribution (marketing), Maalox, Mylanta

The global antacids market will grow from $9.19 billion in 2022 to $9.56 billion in 2023 at a compound annual growth rate (CAGR) of 4.0%.

Key Points: 
  • The global antacids market will grow from $9.19 billion in 2022 to $9.56 billion in 2023 at a compound annual growth rate (CAGR) of 4.0%.
  • The regions covered in the antacids market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
  • The antacids market research report is one of a series of new reports that provides antacids market statistics, including antacids industry global market size, regional shares, competitors with an antacids market share, detailed antacids market segments, market trends, and opportunities, and any further data you may need to thrive in the antacids industry.
  • This antacids market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Two Week Countdown to DeviceTalks West!

Retrieved on: 
Thursday, October 6, 2022
CA, PMA, Conference, Investigational device exemption, CGMP, Medtech, Multimedia, II, Technology, III, Medical device reporting, Compliance, CFR, Medical device, MDR, Processor register, Title 21 of the Code of Federal Regulations, Topical steroid withdrawal, Report, Death, FDA, IDE, View

IRVINE, Calif., Oct. 6, 2022 /PRNewswire/ -- TALG is attending the 2022 DeviceTalks West Conference in Santa Clara, CA. The conference takes place October 19-20, 2022, and we would be thrilled for you to join us! TALG is proud to announce that Ismail Amin, MBEE will be presenting on October 20th on FDA Device Safety & Reporting Best Practices. This session will cover the hundreds of thousands of medical device reports to the FDA concerning reports of alleged device-related injuries, deaths and malfunctions. It will examine the auspices of the FDA Medical Device Report (MDR) scheme and the mandatory reporting requirements. The session will then discuss preparation of relevant systems and protocols to provide manufacturers, distributors and importers with best practices and the Voluntary Malfunction Summary Reporting Program (VMSR) and other proactive approaches to mitigate risk.

Key Points: 
  • IRVINE, Calif., Oct. 6, 2022 /PRNewswire/ -- TALG is attending the 2022 DeviceTalks West Conference in Santa Clara, CA.
  • The conference takes place October 19-20, 2022, and we would be thrilled for you to join us!
  • TALG is proud to announce that Ismail Amin, MBEE will be presenting on October 20th on FDA Device Safety & Reporting Best Practices.
  • Check out DeviceTalks West at DeviceTalks West | Premier MedTech Events to learn more about the conference.

Slope Appoints Clinical Research Veteran Hope Meely as Slope Chief Clinical Officer

Retrieved on: 
Tuesday, July 19, 2022
Supply chain management, Clinical data management, Supply, AstraZeneca, PPD, Inc., Biorepository, Solution, Knowledge, View, Sanofi, Title 21 CFR Part 11, Multimedia, CFR, Industry, Takeda Pharmaceutical Company, Title 21 of the Code of Federal Regulations, Risk, Hope, GlaxoSmithKline, IRTS, Compliance, Clinical trial, Bouquet (EP), Software as a service, SAN, Pharmaceutical industry, Medical imaging, Slope

SAN FRANCISCO, July 19, 2022 /PRNewswire/ -- Slope, provider of the first eClinical Supply Chain Management (eCSCM) platform, announced hiring the clinical research leader, Hope Meely, as Chief Clinical Officer. In her new role, Hope will be instrumental in educating the industry on the new eCSCM software as a service (SaaS) category. Hope will help clinical trial sponsors and research sites understand how replacing existing manual and paper-driven clinical supply chain processes with the Slope eCSCM platform will reduce clinical trial risk and costs, improve the productivity of clinical trial collaborators, and increase subject retention.

Key Points: 
  • SAN FRANCISCO, July 19, 2022 /PRNewswire/ -- Slope , provider of the first eClinical Supply Chain Management (eCSCM) platform, announced hiring the clinical research leader, Hope Meely, as Chief Clinical Officer.
  • Hope will help clinical trial sponsors and research sites understand how replacing existing manual and paper-driven clinical supply chain processes with the Slope eCSCM platform will reduce clinical trial risk and costs, improve the productivity of clinical trial collaborators, and increase subject retention.
  • Hope has spent the last three years leading clinical operations for early-phase oncology clinical trials at Prelude Therapeutics.
  • The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention.

Global Hemostasis Diagnostic Devices and Equipment Market Report 2022: Analyzers, Coagulation Instrument, Hemostasis Instruments, Reagents and Kits - Analysis & Forecasts 2016-2021, 2021-2026F, 2031F - ResearchAndMarkets.com

Retrieved on: 
Friday, May 20, 2022
Biotechnology, Health, Medical Devices, Hemostasis, Coagulation, Pfizer, Disease, Blood, Company, Incidence, Patient, American Heart Association, VCD, Code, CVD, Asia-Pacific, PDP, Title 21 of the Code of Federal Regulations, CSL, Johnson & Johnson, PMA, Bandage, Bleeding, Baxter International, Man, Hospital, Technology, Degenerative disease, Vascular closure device, Skin, Wound healing, Becton, Dickinson and Company headquarters, Collagen, Abbott Laboratories, Laboratory, Classification, Cardiovascular disease, Vasoconstriction, C. R. Bard, Medical device, Medical imaging

The hemostasis diagnostic devices and equipment market consists of sales of hemostasis diagnostic devices.

Key Points: 
  • The hemostasis diagnostic devices and equipment market consists of sales of hemostasis diagnostic devices.
  • The main products of hemostasis diagnostic devices and equipment are analyzers, coagulation instruments, other hemostasis instruments, and reagents and kits.
  • Global Hemostasis Diagnostic Devices And Equipment Market, Segmentation By Product, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
    6.2.
  • Global Hemostasis Diagnostic Devices And Equipment Market, Segmentation By End User, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

Artwork Flow Helps Pharma Companies Comply with 21 CFR Part 11

Retrieved on: 
Thursday, May 19, 2022
Food, Title 21 of the Code of Federal Regulations, List of life sciences, Review, Code, Mondelez International, Textile, Title 21 CFR Part 11, FDA, Johnson & Johnson, CFR, Compliance, Tata Cliq, B2B, Cosmetics, Amazon, Consumer, Medical device, Software as a service, Drink

SOUTH SAN FRANCISCO, Calif., May 19, 2022 /PRNewswire/ -- Artwork Flow, Bizongo's proprietary platform, today announced that its users can now comply with Title 21 of the Code of Federal Regulations (CFR). This will allow customers to fully meet the FDA's requirements for electronic documentation and electronic signatures in their label management journey.

Key Points: 
  • SaaS platform for label proofing, artwork management, and creative collaboration now helps with 21 CFR compliance.
  • SOUTH SAN FRANCISCO, Calif., May 19, 2022 /PRNewswire/ -- Artwork Flow, Bizongo's proprietary platform, today announced that its users can now comply with Title 21 of the Code of Federal Regulations (CFR).
  • To ensure compliance with 21 CFR Part 11 , Artwork Flow allows customers to:
    Automate the production workflow to receive e-signatures from internal and external stakeholders securely.
  • Artwork Flow helps brands across industries such as Food and Beverages, Pharmaceuticals, Cosmetics, Personal Care, Chemicals, Consumer goods, and more.

Global $10.84 Bn Antacids Markets, Analysis, & Forecasts 2016-2021, 2021-2026F, 2031F by Drug Class, Distribution Channel, Formulation Type - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 18, 2022
Medical Supplies, Retail, Health, Other Retail, Pharmaceutical, Food, Beverage, Proton, Title 21 of the Code of Federal Regulations, Constipation, American College, Acid, Boehringer Ingelheim, Biliary reflux, AstraZeneca, OTC, Wickham Laboratories Ltd, Code, Stomach, Bayer, Aluminium, FDA, H2, Takeda Pharmaceutical Company, Efficiency, Hydrogen potassium ATPase, CFR, American College of Gastroenterology, Herbal, Antacid, GlaxoSmithKline, Heartburn, Enzyme inhibitor, Technology, Milk-alkali syndrome, Hypophosphatemia, Mouth, Prevalence, Growth, Osteomalacia, Abbott Laboratories, Absorption, Gastroesophageal reflux disease, Pfizer, Pharmacy, Sleep, Maalox, Mylanta

The "Antacids Global Market Report 2022, By Drug Class, Distribution Channel, Formulation Type" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Antacids Global Market Report 2022, By Drug Class, Distribution Channel, Formulation Type" report has been added to ResearchAndMarkets.com's offering.
  • The antacids market consists of sales of antacids which are used to neutralize stomach acid, and treat acid reflux, heartburn and indigestion.
  • The main classes of antacids are proton pump inhibitors, h2 antagonist, acid neutralizers and pro-motility agents.
  • Proton-pump inhibitors are a type of drug that reduces stomach acid production significantly and for a long time.

InVita Healthcare Technologies Brings Industry First Driver Mobile App to Blood Centers

Retrieved on: 
Wednesday, September 8, 2021

InVita's HemaControl Driver Apptracks blood products in transit from the blood center to the final destination at the hospital.

Key Points: 
  • InVita's HemaControl Driver Apptracks blood products in transit from the blood center to the final destination at the hospital.
  • InVita's HemaControl Driver App tracks blood products in transit from blood center to ultimate destination at hospital.
  • LifeSouth Community Blood Centers, one of the largest U.S. blood centers, rolled out the HemaControl Driver App across all delivery operations.
  • "Without HemaControl and the driver mobile app, there's no transparency or chain of custody between blood centers and their hospital partners.

Global Evaporated Milk Market (2020 to 2027) - Focus on Skimmed and Whole Evaporated Milk - ResearchAndMarkets.com

Retrieved on: 
Monday, September 6, 2021
Food, Beverage, Retail, Food and drink, Drinks, Non-alcoholic drinks, Canned food, Milk, Vegan cuisine, Dairy products, Evaporated milk, Condensed milk, Powdered milk, Lactose intolerance, Milk substitute

The "Global Evaporated Milk Market, By Type (Skimmed Evaporated Milk, Whole Evaporated Milk), By Application (Food Service Cans, Retail), By Region (North America, APAC, Europe, MEA, South America), Estimation & Forecast, 2017 - 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Evaporated Milk Market, By Type (Skimmed Evaporated Milk, Whole Evaporated Milk), By Application (Food Service Cans, Retail), By Region (North America, APAC, Europe, MEA, South America), Estimation & Forecast, 2017 - 2027" report has been added to ResearchAndMarkets.com's offering.
  • The global evaporated milk market held a market value of USD 957.9 Million in 2020 and is estimated to reach USD 1,162.8 Million by the year 2027.
  • Evaporated milk or unsweetened condensed milk is a shelf-stable product made from canned cow's milk.
  • The market is expected to be driven by the high nutritional profile of evaporated milk as compared to regular milk.