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The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps | King & Spalding


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Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the Public Health Service Act (“PHS Act”). Firms will have to think hard about whether to submit investigational new drug applications (“INDs”) or marketing applications, wind down production, or risk running afoul of applicable laws and regulations governing unapproved biological products. They should also be mindful of how data collected to date can help to inform next steps. ....

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MiMedx Welcomes Dirk Stevens, Ph.D., as Senior Vice President, Quality Assurance and Regulatory Affairs


MiMedx Welcomes Dirk Stevens, Ph.D., as Senior Vice President, Quality Assurance and Regulatory Affairs
April 28, 2021 10:21 ET
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MiMedx Group, Inc
MiMedx Group, Inc
Accomplished Regulatory Leader Joins MiMedx Management Team
MARIETTA, Ga., April 28, 2021 (GLOBE NEWSWIRE) MiMedx Group, Inc. (Nasdaq: MDXG) (“MiMedx” or “the Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced the addition of Dirk Stevens, Ph.D., as Senior Vice President, Quality Assurance and Regulatory Affairs, effective May 3, 2021. Dr. Stevens, who brings more than 35 years of strategic leadership experience in quality management and regulatory compliance across multiple medical device and pharmaceutical companies, joins MiMedx from Smith & Nephew, plc, where he was accountable for regulatory submissions, compliance, and Commercial Quality Assurance. ....

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FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products


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SILVER SPRING, Md., Feb. 8, 2021 /PRNewswire/
The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA s Center for Veterinary Medicine:
Veterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products, which include animal cell-based therapies such as stem cells, have the potential to repair diseased or damaged tissues in animals through regeneration and healing.
Today, the U.S. Food and Drug Administration is announcing a listing of clinical field studies that are investigating Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs) in veterinary patients. The webpage provides animal owners, veterinarians, researchers and the public with information on clinical field studies that are being investigated for the use of ACTPs in veterinary patients. ....

Monique Richards , Veterinary Innovation Program , Drug Administration , Veterinary Medicine , Animal Cells , Tissue Based Products , Consumer Inquiries , Us Food And Drug Administration , மொநீக் ரிச்சர்ட்ஸ் , கால்நடை கண்டுபிடிப்பு ப்ரோக்ர்யாம் , கால்நடை மருந்து , விலங்கு செல்கள் , திசு அடிப்படையிலானது ப்ராடக்ட்ஸ் , நுகர்வோர் விசாரணைகள் ,