Updates Guidance Documents - Request for Comment Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food
The purpose of this document is to provide guidance for FDA staff on aflatoxins in human food. We revised this document to update the format and to include revisions for clarity, references to other aflatoxin Compliance Policy Guides (CPGs), and a reference to the Memorandum of Understanding between the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) and FDA. Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations
This guidance provides recommendations regarding in vitro testing of oral drug products, other than solutions, administered via enteral feeding tube (hereinafter enteral tube). These products represent a wide range of oral dosage forms including, but not limited to, granules, pellets, powders, suspensions, capsules, and tablets. Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers
This guidance is intended to address anticipated questions regarding product identifiers that are required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), for packages and homogenous cases of certain drug products. Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
This guidance is intended to aid trading partners3,4 (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined at section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)) and terminating notifications. It does not establish any rights for any person and, with the exception of section IV.B, it is not binding on FDA or the public. With respect to section IV.B, section 582 of the FD&C Act gives FDA authority to issue binding guidance on the process for terminating notifications of illegitimate product. Consumer Updates Should You Put Sunscreen on Infants? Not Usually  When you go outdoors with your infant, whether for a quick stroll in the park or a day at the beach, it's important to keep your little one out of the sun. But should you put sunscreen on your baby to protect them from the sun's bright rays? Not usually. Your infant's sensitive skin is vulnerable to serious burns. But sunscreen isn't the answer, according to the U.S. Food and Drug Administration. That's because infants are at greater risk than adults of sunscreen side effects, such as a rash. The FDA and the American Academy of Pediatrics (AAP) recommend keeping newborns and babies younger than 6 months out of direct sunlight. The best sun protection for these infants is to stay in the shade. Look for natural shade, such as under a tree. Or create your own shade under a beach umbrella, a pop-up tent, or a stroller canopy. [6/3/2021] FDA Voices Innovative Regenerative Medicine Therapies – Patient Safety Comes First  By: Peter Marks, M.D., Director, Center for Biologics Evaluation and Research The U.S. Food and Drug Administration continues to facilitate the development and availability of innovative medical products, such as regenerative medicine therapies, that have the potential to treat or even cure diseases or conditions for which few effective treatment options exist. For example, the agency has recently licensed (approved) its first product that received Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring our ongoing commitment to work with sponsors and manufacturers to bring these products to market. Unapproved products marketed as regenerative medicine therapies may cause serious harm to patients. Cellular therapies, including stem-cell products, are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they haven't been adequately or appropriately studied in clinical trials. [6/3/2021] FDA's Oncology Center of Excellence Launches National Black Family Cancer Awareness Week  By: Richard Pazdur, M.D., Director, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE The U.S. Food and Drug Administration's Oncology Center of Excellence (OCE) is announcing its inaugural National Black Family Cancer Awareness Week (NBFCAW), which will take place from June 17 through June 23, 2021. Throughout the week, the agency's social media platforms will serve as the hub for this historic initiative as participants at health care centers, non-profit associations, and community organizations nationwide raise awareness about the impact of cancer on Black families. Research has shown that cancer awareness can help lower cancer mortality rates and increase life expectancy for all racial and ethnic groups, including Black Americans. [6/1/2021] Webinars and Virtual Workshops Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic
The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about transitioning from use of non-NIOSH-approved disposable respirators. Specifically, the FDA will present information about the May 27, 2021, Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities. This webinar is part of the series on Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use during the COVID-19 Pandemic. June 8, 2021; 12:00 PM - 1:00 PM ET Registration is not required. FDA's work with African Swine Fever from a policy and regulatory perspective
African Swine Fever (ASF) is a highly contagious disease of swine (both farm-raised and wild) that causes significant economic losses to the swine industry in affected countries. The primary transmission of ASF is either pig-to-pig or through a pig consuming contaminated pork, but the virus can also be spread through ticks and inadvertently by humans. The ASF virus is considered a foreign animal disease (FAD) and the USDA has U.S. government lead for prevention, surveillance, and control. Data has emerged to show that animal food can also be a transmission vehicle, and FDA is the primary U.S. government responsible for the oversight of the animal food supply.
June 10, 2021; 12:00 PM - 1:30 PM ET Identification of Medicinal Products: Path to Global Implementation
FDA will present updates on the Identification of Medicinal Products (IDMP) standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form and pharmaceutical identification (PhPID). June 11, 2021; 1:00 PM - 2:30 PM ET Deemed Product Review: A Conversation with the Center for Tobacco Products Office of Science
This meeting is intended to provide information on the scientific review of applications received by Sept. 9, 2020. The meeting will focus on the application intake process, review progress, and allocation of review resources, and include time for audience questions. The meeting is not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review.
June 11, 2021; 1:00 PM - 3:30 PM ET FDA Oncology Center of Excellence: Conversations on Cancer: "National Black Family Cancer Awareness Week: Engaging the Generations" #BlackFamCan
"National Black Family Cancer Awareness Week: Engaging the Generations" #BlackFamCan is a new Oncology Center of Excellence (OCE) Project Community initiative. In accordance with the January 20, 2021 Presidential Executive Order "Advancing Racial Equity and Support for Underserved Communities Through the Federal Government", and in recognition of the 50th anniversary of the National Cancer Act, OCE is engaging NCI-designated Cancer Centers, cancer advocacy groups, patients, social and community organizers, families and friends.
June 17, 2021; 2:00 PM - 3:30 PM ET Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
The Food and Drug Administration (FDA or the Agency) is announcing an annual public meeting and opportunity for public comment on "Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments." 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. June 18, 2021; 9:30 AM - 11:30 AM ET About Us The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living. | 
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