Products

TREATMENT

COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

Docket Number:
FDA-2021-D-0409
Issued by:

Guidance Issuing Office

Oncology Center of Excellence

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s docket number: FDA-2021-D-0409.

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THERAPY

Essent Biologics Launches Human Mesenchymal Stem Cells For Regenerative Medicine, Biopharmaceutical And Cell Therapy Research | New Products Services

CENTENNIAL, Colo., June 8, 2021 /PRNewswire/ — Essent Biologics, a nonprofit biotechnology company setting a new standard in human-derived biomaterials and comprehensive data for research, today announced the launch of its human mesenchymal stem cells (hMSCs) for regenerative medicine, biopharmaceutical and cell therapy research. Essent Biologics will provide highly-characterized, low-passaged hMSCs. Each vial will contain over one million cells at thaw and have a passage level of P0 or P1 to ensure potency.

The company’s hMSCs are the first commercial hMSC product that is recovered, expanded and cryopreserved without the use of antibiotics or animal products. Additionally, with each order of hMSCs, Essent Biologics can provide full donor information coupled with a source biopsy called the Essent Origin Sample™.

“This is an import milestone in getting our products into the hands of brilliant researchers,” said Corey Stone, Executive Director, Essent Biologics. “Our stem cells are

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WEIGHT LOSS

Top Ten Products Online

How To Get Into Ketosis Fast

You’re ready to start the ketogenic diet and uncover the slimmer version of yourself which has been hiding for too long. The only obstacle standing in your way is actually entering ketosis. Instead of looking longingly into where you want to be or dream of a weight you wish you were, you’ve come to the right place to begin your journey.

When approaching any lifestyle change, qualified nutritionists will tell you that in order to make changes stick, it’s important to slowly integrate them and adopt a permanent modification of how you’ve been eating and exercising. However, in order to have the motivation to really stick to a new way of eating, many people need that initial boost. Seeing immediate changes in your body gives you a burst of confidence which will keep you going to lose significant weight

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DENTAL

Penn Dental, Penn Engineering Unite to Form Center for Innovation & Precision Dentistry | New Products Services

PHILADELPHIA, April 13, 2021 /PRNewswire/ — With the shared vision to transform the future of oral health care, Penn Dental Medicine and Penn’s School of Engineering and Applied Sciences have united to form the Center for Innovation & Precision Dentistry (CiPD). Conceived and brought to fruition by co-directors Dr. Michel Koo of Penn Dental Medicine and Dr. Kathleen Stebe of Penn Engineering, the CiPD is bridging the two schools through cutting-edge research and technologies to accelerate the development of new solutions and devices to address unmet needs in oral health, particularly in the areas of dental caries, periodontal disease, and head and neck cancer. The CiPD will also place a high priority on programs to train the next generation of leaders in oral health care innovation.

“There is an urgent need to find better ways to diagnose, prevent, and treat oral diseases, particularly in ways that are affordable

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TREATMENT

The Best Natural Gum Regrowth Products 2021 | by Lindaa Raynor

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TREATMENT

Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment

Docket Number:
FDA-2000-D-0037
Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

The purpose of this guidance is to provide recommendations to sponsors for the development of drugs, biological products, and devices2 to treat chronic cutaneous ulcer and burn wounds (i.e., wound-treatment products). The first part of this guidance addresses specific preclinical considerations. The guidance then addresses important considerations in clinical study design, including endpoint selection and manufacturing.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s docket number: FDA-2000-D-0037.

Source Article Read More

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THERAPY

Physical Education Equipment – Recreational Products

Call us at 800.793.7900 if there is anything we can do to help you!

Call us at 800.793.7900 if there is anything we can do to help you!



FlagHouse: Helping everyone play, learn and enjoy life fully.

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  • Portable Wiggle Seat

    This lightweight sensory cushion comes

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