Updates Guidance Documents Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues
This guidance describes the FDA's current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer. Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide
This guidance is intended to help small entities better understand the final rule, "Importation of Prescription Drugs," published October 1, 2020 (85 FR 62094). The Secretary of Health and Human Services issued the final rule to implement section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384(b) through (h)) to allow importation of certain prescription drugs from Canada. The purpose of the final rule is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public's health and safety. Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)
The FDA is announcing the availability of a draft guidance for industry entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1)." The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs, and it provides updates to the options for development programs, given the availability of some new therapeutic options. Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components
We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy
This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) for transfusion or for further manufacturing use, including Source Plasma. Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
This guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. ICYMI! FDA's "All-in" Approach to Enterprise Transformation  By: Janet Woodcock, M.D., Principal Deputy Commissioner, and Meredith Chuk, M.D., Senior Medical Advisor, Director, Enterprise Transformation Operation The FDA's responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every home and used every day across the U.S. As we witnessed during the pandemic, the FDA plays a critical role in enabling access to safe and effective medical products, such as vaccines, therapeutics, and accurate diagnostic testing. The agency also monitors and supports the supply chains for critical components of these products, while continuing to ensure the safety of our food supply, all in an increasingly complex and interconnected environment. FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program  By: Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of CDER (pictured below)  Part of the FDA's mission is to protect and promote public health by helping to ensure that safe, effective, quality drugs are available to patients. Drugs are not available to patients if they are in shortage. The 2019 report Drug Shortages: Root Causes and Potential Solutions found that a root cause of past drug shortages is that the market does not recognize and reward drug manufacturers that have invested in achieving quality management maturity (QMM). QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes in place to achieve quality objectives and promote continual improvement. Such business processes reduce the likelihood of supply disruptions and shortages. | Webinars and Virtual Workshops Regulatory Education for Industry (REdI) Annual Conference 2022 June 6 - 10, 2022; 8:30 AM - 4:50 PM ET Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements, and also create awareness of current activities. The FDA will review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products such as vaccines, drugs, diagnostics, and personal protective equipment. Vaccines and Related Biological Products Advisory Committee June 7, 2022; 8:30 AM - 5:00 PM ET The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older. Registration is not required. 2022 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments June 7, 2022; 9:30 AM - 10:50 AM ET This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II. These user fee programs were reauthorized as part of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) signed by the President on August 18, 2017. Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration June 7 - 9, 2022; 1:00 PM - 4:00 PM ET The purpose of the public workshop is to discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). The RSCP aims to build upon a foundation of strong partnerships to improve supply chain resiliency through proactive communication, collaboration, and engagement with patient advocates, health care providers, distributors, group purchasing organizations, manufacturers, as well as key component and material suppliers. Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement June 8, 2022; 9:30 AM - 5:15 PM ET The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione. The chart below identifies the use(s) FDA reviewed for each of the four bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances or another interested party will be invited to make a short presentation supporting the nomination. Registration is not required. Some Perspectives on Data Science and Coronaviruses June 9, 2022; 9:00 AM - 10:00 AM ET This lecture will present some perspectives, illustrated with recent COVID-19 experience and examples, on how in silico modelling and data science techniques could strengthen nonclinical (in vitro and animal) models for existing and emerging coronaviral diseases. Vaccines and Related Biological Products Advisory Committee June 14 - 15, 2022; 8:30 AM - 5:00 PM ET The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the following: On June 14, 2022, under Topic 1, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age. On June 15, 2022, under Topic II, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age. Registration is not required. Conversations on Cancer: "National Black Family Cancer Awareness Week: Engaging the Generations" June 16, 2022; 1:00 PM - 2:30 PM ET  The 2022 Conversations on Cancer: National Black Family Cancer Awareness Week public panel discussion is also in keeping with the Cancer Moonshot 2.0 which established goals to reduce cancer death rates by at least 50% over the next 25 years and improve the experience of living with and surviving cancer. OCE is engaging NCI-designated Cancer Centers, cancer advocacy groups, patients, social and community organizers, Historically Black Colleges and Universities, families and friends. OCE's Project Community is keenly interested in including members of all US communities in this dialogue. Vaccines and Related Biological Products Advisory Committee June 28, 2022; 8:30 AM - 5:00 PM ET The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. Registration is not required. FDA Workshop: 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop June 29, 2022; 10:00AM - 3:00 PM ET The overarching aim of this year's workshop remains the same as in past years - to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. About Us The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. Did someone forward you this email? Sign up below! | 
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