Federal Food, Drug, and Cosmetic Act

Sientra Announces FDA-Clearance of Next Generation AlloX2 Pro™ Tissue Expander

Retrieved on: 
Thursday, June 8, 2023
Federal Food, Drug, and Cosmetic Act, Drainage, Quality of life, Woman, Food and Drug Administration Amendments Act of 2007, Magnetic resonance imaging, Patient, Health, FDA, Paediatric-use marketing authorisation, Food, Breast cancer, Medical imaging

IRVINE, Calif., June 08, 2023 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a medical aesthetics company focused on enhancing lives by advancing the art of plastic surgery, announced that the Food and Drug Administration (FDA) has granted a 510k-clearance for the Company’s novel, patented1 AlloX2 Pro Tissue Expander. Building upon the proprietary dual port technology of the Company’s ground-breaking AlloX2® tissue expander, the AlloX2 Pro expands this platform by removing 95% of the metal traditionally associated with tissue expander ports. This innovation allows the AlloX2 Pro to be labeled as MRI-conditional, making it the only tissue expander cleared in the United States for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients.   Other innovative features of the AlloX2 Pro include minimal interference with radiation therapy for post-mastectomy patients,2 faster port filling and drainage, and a softer drain for enhanced patient comfort.

Key Points: 
  • Building upon the proprietary dual port technology of the Company’s ground-breaking AlloX2® tissue expander, the AlloX2 Pro expands this platform by removing 95% of the metal traditionally associated with tissue expander ports.
  • This innovation allows the AlloX2 Pro to be labeled as MRI-conditional, making it the only tissue expander cleared in the United States for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients.
  • Other innovative features of the AlloX2 Pro include minimal interference with radiation therapy for post-mastectomy patients,2 faster port filling and drainage, and a softer drain for enhanced patient comfort.
  • “I am extremely proud to have partnered with Sientra to bring the AlloX2 Pro to market,” commented Dr. Thomas McClellan, a board-certified plastic surgeon in West Virginia and inventor of AlloX2.

PaxMedica Completes HAT-301 Registrational Trial for PAX-101

Retrieved on: 
Thursday, June 1, 2023
Real, Suramin, PRV, Natural history, Priority review, Infection, African, NDA, Federal Food, Drug, and Cosmetic Act, GAO, Patient, Standard of care, ASD, APT, FDA, TBR, FD, Food, Pharmaceutical industry, Autism spectrum

TARRYTOWN, NY, June 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD), and other serious conditions with intractable neurologic symptoms, today announced that the eligibility review and final enrollment for the company’s Real World Evidence study (HAT-301) has been completed. Patient eligibility was assessed for inclusion by an Independent Study Adjudication Committee which included a total of three subject matter expert medical reviewers.

Key Points: 
  • Patient eligibility was assessed for inclusion by an Independent Study Adjudication Committee which included a total of three subject matter expert medical reviewers.
  • Howard Weisman, Chief Executive Officer of PaxMedica, commented, “Database lock for the HAT-301 study is a significant threshold event for PAX-101.
  • With this achievement, PaxMedica has completed a critical step in filing for potential U.S. market approval for this important, life-saving treatment.
  • This remains central to our strategy to build and support sustainable long term shareholder value.”

AAMI, BSI Join Forces to Publish Guidance on Artificial Intelligence

Retrieved on: 
Wednesday, May 31, 2023
International Electrotechnical Commission, BSI, Regulation of tobacco by the U.S. Food and Drug Administration, AAMI, American National Standards Institute, SC, ISO, Internet Technical Committee, Risk management, Intelligence, British Standards, Cosmetic, Standard, Federal Food, Drug, and Cosmetic Act, Patient, Machine learning, Artificiality, Artificial intelligence, IEC, CR, Philips, AI, Health, International Organization (journal), TC, Food, Safety, International Organization for Standardization, Software, Medical device, Agency

Arlington, VA, May 31, 2023 (GLOBE NEWSWIRE) -- AAMI and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.

Key Points: 
  • Arlington, VA, May 31, 2023 (GLOBE NEWSWIRE) -- AAMI and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.
  • AAMI Technical Information Report (TIR)34971:2023, Application of ISO 14971 to machine learning in artificial intelligence – Guide , derives from a 2022 AAMI consensus report (CR).
  • The British Standard is designated as BS/AAMI 34971:2023, Application of ISO 14971 to machine learning in artificial intelligence — Guide.
  • “The key difference about the TIR is that we’re doing it jointly with BSI,” said Hae Choe, principal director of standards at AAMI.

ZIVO’s GRAS Designation Reaffirmed for Proprietary Algal Biomass Product as a Human Food Ingredient

Retrieved on: 
Tuesday, May 30, 2023
Agriculture, Biotechnology, Natural Resources, Pharmaceutical, Health, Food, Beverage, Retail, Other Health, GRAS, FDA, Drink, Biomass, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Federal Food, Drug, and Cosmetic Act, Cosmetic, Safety, Dietary supplement

GRAS is a designation created by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act that determines if a food ingredient or additive has adequate evidence of safety to be consumed under the conditions of intended use.

Key Points: 
  • GRAS is a designation created by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act that determines if a food ingredient or additive has adequate evidence of safety to be consumed under the conditions of intended use.
  • GRAS status conveys to manufacturers and marketers that they are able to safely integrate ZIVO’s algal biomass ingredient into food processing lines and products, and to include its nutritional information on product labels.
  • The present GRAS review is based on commercial-scale cultivation processes and parameters, which better represent ZIVO’s planned commercial product.
  • The analysis concludes that ZIVO’s algal biomass, as cultivated for commercial use, is exempt from the premarket approval requirements of the FDA.

FDA Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettes

Retrieved on: 
Wednesday, May 31, 2023
Failure, Heated tobacco product, CTP, Sale, Federal Food, Drug, and Cosmetic Act, Puff Bar, Seizure, Center for Tobacco Products, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Tobacco, Dietary supplement, Puff

"Protecting our nation's youth from tobacco products – including disposable e-cigarettes – is a top priority for the FDA," said FDA Commissioner Robert M. Califf, M.D.

Key Points: 
  • "Protecting our nation's youth from tobacco products – including disposable e-cigarettes – is a top priority for the FDA," said FDA Commissioner Robert M. Califf, M.D.
  • All products cited in the warning letters are disposable e-cigarettes, which are the most commonly used e-cigarette product type among youth.
  • These efforts include ongoing surveillance of the marketplace to identify violative products, including existing and emerging disposable e-cigarette products.
  • FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth.

Cybeats Signs Trial License with Top-5 Global Medical Device Manufacturer

Retrieved on: 
Wednesday, May 31, 2023
Medical device, Regulation of tobacco by the U.S. Food and Drug Administration, CSE, CYBT, Data management, RTA, Omnibus spending bill, Risk management, Risk assessment, SBOM, Automotive industry, Industrial control system, Consolidated Appropriations Act, 2016, ICS, Omnibus, Organization, Federal Food, Drug, and Cosmetic Act, MDM, FDA, FD, Food

TORONTO, May 30, 2023 /PRNewswire/ - Cybeats Technologies Corp. ("Cybeats'' or the "Company") (CSE: CYBT) (OTCQB: CYBCF) is pleased to announce a trial license agreement for SBOM Studio1 with a Top-5 global medical device company, marking its 3rd engagement from the Medical Device Manufacturing ("MDM") Global Top-10.

Key Points: 
  • TORONTO, May 30, 2023 /PRNewswire/ - Cybeats Technologies Corp. ("Cybeats'' or the "Company") (CSE: CYBT) (OTCQB: CYBCF) is pleased to announce a trial license agreement for SBOM Studio1 with a Top-5 global medical device company, marking its 3rd engagement from the Medical Device Manufacturing ("MDM") Global Top-10.
  • Cybeats SBOM Studio delivers comprehensive software supply chain intelligence technology, empowering organizations to effectively manage Software Bill of Materials ("SBOM") and proactively addresses cyber risks in their medical device projects.
  • This section mandates that Medical Device Manufacturers ("MDM") provide a SBOM for their devices' commercial, open-source, and off-the-shelf software components.
  • Cybeats, already serving one of the largest global MDMs, is in trial evaluations and late-stage contract negotiations with several other leading MDMs worldwide.

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

Retrieved on: 
Thursday, May 25, 2023
EUA, Taste, Post-exposure prophylaxis, Vaccine, Shenzhen Kangtai Biological Products, Office of Inspector General, U.S. Department of Health and Human Services, Diarrhea, Hospital, Center for Drug Evaluation and Research, Human services, Public, COVID-19, Clinical trial, Immunity, Food, Cosmetics, Multimedia, RNA, Animal, Federal Food, Drug, and Cosmetic Act, Dietary supplement, Patient, Risk, Diagnosis, Heated tobacco product, Research, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Disease, Pharmaceutical industry, SARS-CoV-2, Nirmatrelvir/ritonavir

Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.

Key Points: 
  • Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
  • The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19."
  • EPIC-HR was a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection.
  • Based on the data currently available to the FDA, there is not a clear association between Paxlovid treatment and COVID-19 rebound.

Cybeats Announces License Agreement with Starfish Medical, Canada's Largest Contract Medical Device Design, Development and Contract Manufacturer

Retrieved on: 
Monday, May 22, 2023
Agreement, Regulation of tobacco by the U.S. Food and Drug Administration, CSE, TSX Venture Exchange, Medical device, CYBT, Marketing, RTA, Food, Omnibus spending bill, Disclosure, Starfish, Risk assessment, SBOM, Consolidated Appropriations Act, 2022, Person, Omnibus, Federal Food, Drug, and Cosmetic Act, Gold standard, GSM, Good, FDA, MDM, FD

Cybeats SBOM Studio delivers comprehensive software supply chain intelligence technology, empowering StarFish to effectively manage Software Bill of Materials ("SBOM") and proactively address cyber risks in their medical device projects.

Key Points: 
  • Cybeats SBOM Studio delivers comprehensive software supply chain intelligence technology, empowering StarFish to effectively manage Software Bill of Materials ("SBOM") and proactively address cyber risks in their medical device projects.
  • This recent contract with a medical device firm underscores the growing expertise in the healthcare security industry vertical and increasing demand for SBOM solutions within the industry.
  • This section mandates that Medical Device Manufacturers ("MDM") provide a SBOM for their devices' commercial, open-source, and off-the-shelf software components.
  • Cybeats, already serving one of the largest global MDMs, is in trial evaluations and late-stage contract negotiations with several other leading MDMs worldwide.

South Carolina is the First state in 2023 to be “SUNucated”

Retrieved on: 
Wednesday, May 17, 2023
Life, Curriculum, Skin cancer, Dermatology, School, Personal protective equipment, Student, American Society of Interventional Pain Physicians, Federal Food, Drug, and Cosmetic Act, MD, Risk, Weather, FRCPC, Society, Legislation, Nursing

The law, signed by Governor Henry McMaster, also enables children to wear protective clothing and allows schools to teach students sun safety curriculum.

Key Points: 
  • The law, signed by Governor Henry McMaster, also enables children to wear protective clothing and allows schools to teach students sun safety curriculum.
  • South Carolina is the 27th state to adopt model legislation that is the foundation of the SUNucate initiative developed by the American Society for Dematologic Surgery Association (ASDSA) to address barriers to sunscreen use in school and camps and promotes sun-safe behaviors.
  • “I congratulate South Carolina on passing this critical common-sense legislation to instill sun-safe habits and protect children from overexposure to the sun,” said ASDSA President Vince Bertucci, MD, FRCPC.
  • Sunscreens are regulated as over-the-counter drugs under the Federal Food, Drug and Cosmetic Act, making them subject to these bans.

Minerva Neurosciences Reports 2023 First Quarter Financial Results and Business Updates

Retrieved on: 
Monday, May 15, 2023
Insurance, Roluperidone, Small business, NERV, Schizophrenia, Federal Food, Drug, and Cosmetic Act, New Drug Application, NDA, RTF, G&A, Research, Sale, Waste, Patient, Physician, Myenteric plexus, Neuroscience, PDUFA, R, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Caregiver, Pharmaceutical industry, Cryptocurrency

BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter ended March 31, 2023.

Key Points: 
  • BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter ended March 31, 2023.
  • The Company submitted a Formal Dispute Resolution Request (FDRR) on March 2, 2023, and met with the FDA on March 28, 2023.
  • On May 8, 2023 , the FDA confirmed that they had assigned a PDUFA goal date of February 26, 2024.
  • In January 2023 we received a refund of our NDA filing fee of $3.1 million from the FDA.