Welcome to another installment of This Week at FDA, your weekly source for updates big and small on FDA, drug and medical device regulation and what were reading from around the web. This was a busy week for FDA in Congress, with hearings in both chambers touching on FDAs user fee programs, FY2023 budget request, and more. We also saw FDA release a tentative schedule for several upcoming advisory committee meetings to discuss COVID-19 vaccines. Plus, we learned that Moderna has submitted an emergency use authorization (EUA) request for its vaccine in children under 6 years of age.Earlier today, FDA announced that it is holding dates in June for several upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings to discuss some hot button issues related to COVID-19 vaccines. First, the committee is slated to discuss Novavaxs EUA request for its COVID-19 vaccine in adults on 7 June. The agency is holding three dates throughout the month for the committee to discuss extending the use of Pfizer and Modernas vaccines for younger children. On 28 June, the committee is set to meet again to discuss whether the SARS-CoV-2 strain composition of vaccines should be modified in time for the fall.We also got word that Moderna has submitted an EUA request to expand the use of its COVID-19 vaccine to children ages 6 months to 6 years of age. During his testimony on FDAs FY2023 budget request, Califf told the HELP committee the agency would move quickly to review the request. Previous reports suggested that FDA was considering waiting until it had a similar request from Pfizer in hand so it could potentially authorize both shots at the same time.It was a packed week on the Hill, with FDAs medical product center directors testifying before the Senate Health, Education, Labor and Pensions (HELP) committee on the agencys user fee programs on 26 April. FDA Commissioner Robert Califf appeared before the Senate Appropriations committee on 28 April to discuss the agencys FY2023 budget request. The House Appropriations hearing on the agencys FY2023 was originally slated for 27 April, though the hearing was postponed.Other FDA-related hearings this week included a hearing on 27 April on consulting firm McKinseys conflicting work on FDA contracts while it was consulting for opioid makers, including Purdue Pharma, and the House Select Subcommittee on the Coronavirus Crisis hearing earlier today on political interference at federal health agencies during the pandemic. Health and Human Services (HHS) Secretary Xavier Becerra testified before the House Energy & Commerce committee on 27 April on the administrations FY2023 budget request for HHS and all its sub-agencies.CDER Director Patrizia Cavazzoni said the center is not currently contracting with McKinsey and that the agency anticipates that further contracts will not be issued, while investigations are pending.Drugs & biologicsFDA has released data on its generic drug program performance for the first half of FY2022, as well as activity reports for the same period under Section 805 and 807 of the FDA Reauthorization Act.CDER also posted a discussion with Darshini Satchi, deputy director of the Division of Information Disclosure Policy within the Office of Regulatory Policy about the centers efforts to make materials public while complying with the Freedom of Information Act (FOIA) and other public disclosure laws.CBER, meanwhile announced its annual Patient Engagement & Regenerative Medicine Meeting, which will be held on 24 May 2022.MedtechAfter a long wait, FDA finally released the meeting minutes for the remainder of its negotiation sessions with industry on the Medical Device User Fee Amendments (MDUFA V) agreement. Minutes for more than a dozen meetings held since last summer were posted this week after the center was criticized for failing to post them on time.FDA issued several alerts about safety issues pertaining to specific medical devices this week. It warned that patients with Medtronics Heartware Ventricular Assist Device (HVAD) system who appear to present with pump thrombosis may have a weld defect in their device. The advisory was sent to healthcare providers after Medtronic issued an urgent medical device correction about the issue.Additionally, the agency advised healthcare providers of the risk of airway obstruction when using certain electromyogram endotracheal tubes marketed by Medtronic. The Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube are the only two silicone-based EMG on the market. FDA said it has received reports of serious adverse events and deaths after airway obstruction for silicone-based EMG endotracheal tubes, and has not received similar reports regarding PVC-based EMG tubes.Medtronic also recalled its Harmony Delivery Catheter, which is part of its Transcatheter Pulmonary Valve (TPV) system due to the risk of capsule breakage during use. FDA notes that there have been 6 reported complaints from clinical cases, one injury, and no deaths associated with the use of these devices.In other recall news, FDA announced that Celltrion USA has recalled some point-of-care DiaTrust COVID-19 Ag Rapid Test Kits that have inadvertently been distributed to unauthorized users. The test should only be used by CLIA-certified laboratories.CDRH also qualified the FACE-Q | Aesthetics patient-reported outcome (PRO) as a medical device development tool (MDDT) that can be used facilitate the evaluation of medical devices. The FACE-Q tool is intended to assess the outcomes of aesthetic facial procedures and is comprised of three modules: Self-Perceived Facial Appearance, Health-Related Quality of Life and Adverse Effects of Treatment.The center also classified the autofluorescence detection device for general surgery and dermatological use into class II (special controls).
2022Regulatory Affairs Professionals Society.
- Regenerative medicine UKRI - UK Research and Innovation - December 10th, 2023
- What Is Regenerative Medicine? | Goals and Applications | ISCRM - December 2nd, 2023
- What Is Regenerative Medicine? | Mass General Brigham - December 2nd, 2023
- Advancing Safe and Effective Regenerative Medicine Products - March 20th, 2023
- Can This Companys Research Help Transform Regenerative Medicine As Its ... - December 18th, 2022
- Regenerative Medicine in Pharma Market Size, Share and Trends Analysis by Region, Drug Class, Route of Administration, and Segment Forecast, 2022-2027... - December 10th, 2022
- Stem Cells Applications in Regenerative Medicine and Disease ... - November 16th, 2022
- Neuroregeneration - Center for Regenerative Biotherapeutics - Mayo ... - November 16th, 2022
- Journal of Immunology and Regenerative Medicine - ScienceDirect - November 16th, 2022
- A Look At Some Of The Companies Innovating In the Cutting-Edge ... - November 16th, 2022
- Regenerative Medicine Advanced Therapy Designation | FDA - October 29th, 2022
- Packing More Punch for Regenerative Medicine and Cell and Gene Therapies - Inside Precision Medicine - October 29th, 2022
- Brush Up: Tissue Engineering and Regenerative Medicine - The Scientist - October 21st, 2022
- The Alliance for Regenerative Medicine Announces Election of 2023 Officers, Executive Committee, and Board of Directors - GlobeNewswire - October 13th, 2022
- Husband and Wife Team Bring Regenerative Medicine Clinic to Jackson - Franchising.com - October 13th, 2022
- Hundreds run for regenerative medicine research at the 2022 TCS London Marathon - British Heart Foundation - October 13th, 2022
- Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss - Yahoo Finance - October 13th, 2022
- SANUWAVE's Energy First Technology to be Featured in 3 Clinical Posters at Upcoming 2022 Fall Symposium on Advanced Wound Care (SAWC) -... - October 13th, 2022
- 3D Bioprinting Market Size to Touch Valuation of $1.5 Billion by 2028 | Inkjet Technology Generates More than 38% Revenue of Bioprinting Market -... - October 13th, 2022
- QC Kinetix (Columbia) Offers Regenerative Medicine Treatments to Treat Different Types of Physical Pain and Injuries - Yahoo Finance - October 4th, 2022
- Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative... - October 4th, 2022
- Company / An Advance In Vaginal Rejuvenation, Regenerative Medicine And Aesthetic Gynecology - World Nation News - October 4th, 2022
- Performance Rehabilitation and Regenerative Medicine's Dr. Joseph Mejia honored as a Castle Connolly Top Doctor - Jersey's Best - October 4th, 2022
- Teijin, J-TEC, Mitsui Fudosan, and NCC to create a new platform for regenerative medicine innovation - The Worldfolio - October 4th, 2022
- Cell Regeneration Medicine Market to be valued at US$ 34.3 Bn by the end of 2022 | FMI Research - PharmiWeb.com - October 4th, 2022
- Enlivex to Present at the 4th Macrophage-Directed Therapies Summit - Yahoo Finance - October 4th, 2022
- Fracturing bones and traditional views of civil engineering - ASU News Now - October 4th, 2022
- BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA - PR... - October 4th, 2022
- Organ on a Chip Market - Focus on Products and Technologies - Distribution by Type of Product, Application Area, Purpose, and Key Geographical Regions... - October 4th, 2022
- QC Kinetix (Riverside Parkway) Offers Regenerative Medicine Treatments to Treat Pain and Injuries in Tulsa, OK - Yahoo Finance - September 25th, 2022
- Reprogramming pig cells leads way for new regenerative therapies - National Hog Farmer - September 25th, 2022
- Research Roundup: Regenerative Potential, Long COVID Insights, Immuno-Oncology and More - BioSpace - September 25th, 2022
- Dr. Batcheller's Wellness and Esthetics, Mecca for Regenerative Medicine and Esthetics - Digital Journal - September 25th, 2022
- Organicell Regenerative Medicine, Inc. Announces Expansion of Management Team - Yahoo Finance - September 25th, 2022
- Pfizer and Sangamo Therapeutics Announce Phase 3 Trial of Investigational Gene Therapy for Hemophilia A Has Re-Opened Recruitment - Pfizer - September 25th, 2022
- Neurona Therapeutics Presents Clinical Case Study from First Human Trial of Regenerative Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal... - September 25th, 2022
- Center for Breakthrough Medicines (CBM) and jCyte Announce Strategic Partnership to Manufacture jCyte's Innovative Cell Therapy for Treatment of... - September 25th, 2022
- 2022 UK Equine Research Hall of Fame Inductees Announced The Horse - TheHorse.com - September 25th, 2022
- Science on the go: Catch the Veterinary Vertex podcast - American Veterinary Medical Association - September 25th, 2022
- Advanced robotics to address the translational gap in tendon engineering - EurekAlert - September 25th, 2022
- Russ Olsen Makes Multi-Million Dollar Pledge in support of the Robert Morris University Library - Robert Morris University - September 25th, 2022
- Humacyte Expands Board of Directors and Leadership Team with New Appointments - Yahoo Finance - September 25th, 2022
- First time in India: Stem cell therapy to treat knee osteoarthritis - Moneycontrol - September 25th, 2022
- George Church: Learn from COVID and fast-track therapies that reverse aging - Longevity.Technology - September 25th, 2022
- EpiBone CEO and Co-Founder Dr. Nina Tandon Selected to Participate in White House Summit - PR Web - September 25th, 2022
- Krystal Biotech Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC for the treatment of Dystrophic... - September 25th, 2022
- Humacyte Announces Presentations by Ukrainian Surgeons on Use of the Human Acellular Vessel to Treat Wartime Vascular Trauma at the European Society... - September 25th, 2022
- Fertility Supplements And Vitamins For Women: What You Need To Know - Forbes - September 25th, 2022
- CIRM awards UCI $2.7 million to create regenerative medicine training program - UCI News - September 16th, 2022
- Regenerative Medicine Hub at W-S Innovation Quarter keeps growing with new addition - WRAL TechWire - September 16th, 2022
- QC Kinetix (Chandler): The Future of Regenerative Medicine in Arizona - Digital Journal - September 16th, 2022
- Platelet-Rich Plasma: A Promising Regenerative Therapy in Gynecological Disorders - Cureus - September 16th, 2022
- 4 to be inducted into UK Equine Research Hall of Fame - WTVQ - September 16th, 2022
- FACT SHEET: The United States Announces New Investments and Resources to Advance President Bidens National Biotechnology and Biomanufacturing... - September 16th, 2022
- AVITA Medical Achieves Positive Topline Pivotal Trial Results for Treatment of Stable Vitiligo Using the RECELL System - Yahoo Finance - September 16th, 2022
- Cell Culture Media Market worth $10.3 billion by 2026 - Exclusive Report by MarketsandMarkets - GlobeNewswire - September 16th, 2022
- Following some big FDA wins, Carmell Therapeutics plans to go public. Here's why - Technical.ly - September 16th, 2022
- Pharmaceutical Drug Delivery Market is expected to generate a revenue of USD 2,583 Billion by 2030, Globally, at 6.6% CAGR: Verified Market Research -... - September 16th, 2022
- Capstan Therapeutics Launches with $165 Million to Deliver on the Clinical Promise of Precise In Vivo Cell Engineering - Business Wire - September 16th, 2022
- Children's Health will fund pediatric unit at the Texas Health and Human Services Commission UT Southwestern Medical Center psychiatric hospital - UT... - September 16th, 2022
- Cell Line Development Market Projected to Experience a CAGR of 5% from 2022 to 2032, value worth US$ 7.66 Billion | Future Market Insights, Inc. -... - September 16th, 2022
- UB researchers identify new model of cerebral cortex development linked to reelin protein expression - EurekAlert - September 16th, 2022
- NYC Dermatologist, Dr. Julie Russak, launches first Anti-Aging Wellness Program of its kind in the U.S. - PR Web - September 16th, 2022
- About Regenerative Medicine - Center for Regenerative Biotherapeutics ... - September 8th, 2022
- Global Exosome Market Report 2022: Integration into Fields of Liquid Biopsy, Precision Medicine, and Regenerative Medicine Driving Growth -... - September 8th, 2022
- Addressing Diversity Barriers to Regenerative Medicine Free Press of Jacksonville - Jacksonville Free Press - September 8th, 2022
- Looking to buy Mesoblast shares? Here's the latest on where the ASX biotech is at with the FDA - The Motley Fool Australia - September 8th, 2022
- Sernova Announces the Appointment of Daniel Mahony, Ph.D. to its Board of Directors - GlobeNewswire - September 8th, 2022
- 7.5 Million Granted to Collaborative PROTO Project led by Charit to Study Pluri's PLX-PAD Cells for Osteoarthritis Treatment - GlobeNewswire - September 8th, 2022
- Regenerative Medicine Market to Garner Bursting Revenues [+USD 27.29 Billion] with Top Growing Companies During 2022-2029 - eTurboNews | eTN - August 30th, 2022
- ElevateBio Partners with the California Institute for Regenerative Medicine to Accelerate the Development of Regenerative Medicines - Business Wire - August 30th, 2022
- Global Cell Therapy Market to Reach a Capital Expenditure of USD 10.23 billion in 2021 - eTurboNews | eTN - August 30th, 2022
- Therapeutic Solutions International Develops Gene Silencing Therapy for Acute Respiratory Distress Syndrome - BioSpace - August 30th, 2022
- How Astrocytes May Be Able to Help With Brain Repair - Best Health Magazine - August 30th, 2022
- Applied StemCell Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy - Business Wire - August 30th, 2022
- Scientists just bypassed millions of years worth of evolution in mice - Inverse - August 30th, 2022
- NIAMS Update, Issue 4, 2022 | NIAMS - National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - August 30th, 2022
- Heart Association fellowship to support research - Binghamton - August 30th, 2022
- Climate change is making the new school year harder in all kinds of ways - Salon - August 30th, 2022
- Global Biomaterials Market to Reach Value of $372.7 Billion by 2028 | Demand For Biomaterials in the Healthcare Industry will Grow by 53% Over the... - August 30th, 2022