Updates Guidance Documents - Request for Comment Remanufacturing of Medical Devices: Draft Guidance
This draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. In drafting this guidance, FDA considered objective evidence and information learned from the Agency's activities discussed in this draft guidance. Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
This guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to follicle-stimulating hormone and estradiol), in breast cancer clinical trials. The issues of fertility and fertility preservation when treating premenopausal women with breast cancer are outside the scope of this guidance and are not addressed. Consumer Updates How to Report Problems with Flea and Tick Products  Fleas and ticks can be more than just an itchy annoyance to your pets—they can cause serious harm. So it's important to know how to use flea and tick products safely. It's also important to know whom to report to if you're experiencing problems with these products. Flea and tick products for pets are regulated by either the Food and Drug Administration or the Environmental Protection Agency (EPA). FDA and EPA have an interagency committee that evaluates products on a case-by-case basis to determine the appropriate regulatory agency. Have You Given Blood Lately?  Every day, hospitals throughout the United States transfuse blood or blood components, such as platelets, to save the lives of people who are in motor vehicle accidents, and victims of fires and other emergencies. Blood is also required for many people with life-threatening illnesses and others undergoing routine surgeries. According to the Centers for Disease Control (CDC), blood centers and hospitals in the U.S. collect and transfuse millions of units of blood each year. In fact, every two seconds, someone in America needs blood, according to the American Red Cross (ARC). Men With Breast Cancer Need More Treatment Options and Access to Genetic Counseling  Although breast cancer is a disease usually associated with women, men can get it too. Because male breast cancer is rare, there is very limited information on how to treat men diagnosed with the disease. "In the absence of better information to guide us, we tend to treat men with breast cancer the same way we treat women," says Tatiana M. Prowell, M.D., a breast cancer scientific liaison at the U.S. Food and Drug Administration. "Men have historically been excluded from breast cancer clinical trials. In the last few years, we've begun asking drug companies to allow men in clinical trials unless there is a valid scientific reason to exclude them." Older Therapies Aren't Necessarily Better for Thyroid Hormone Replacement  Millions of people have thyroid glands that don't make enough thyroid hormone to meet their body's needs. Hypothyroidism, also called underactive thyroid, is the most common reason some people need thyroid hormone replacement. Hypothyroidism is treated by replacing the hormones that your own thyroid can no longer make. Thyroid hormone medicines mimic these hormones. Thyroid hormone has been used as medicine for decades. The first versions of thyroid hormone medicines were made from the thyroid glands of pigs or cows and are not approved by the U.S. Food and Drug Administration. Today, there are modern, synthetic (laboratory-made) medications approved by the FDA. Most patients with hypothyroidism use these modern thyroid replacement drugs. ICYMI!  FDA's Center for Drug Evaluation and Research announced an updated online continuing education (CE) course titled "FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond." The revised course provides an overview of the FDA drug regulatory process and the science that supports the FDA mission. The course provides 1.5 hours of free continuing education credit to health care providers about the basics of the FDA drug regulatory process and the science that supports this mission in CDER. It will also educate the nation's health care providers about their role in communicating drug information to their patients. Webinars and Virtual Workshops FDA-Arthritis Foundation Osteoarthritis Drug Development Workshop: Assessment of Long-term Benefit
The FDA and the Arthritis Foundation (AF) have joined forces for this workshop to leverage their combined strengths to bring together subject matter experts in the field of diagnosis, research, development, and treatment of OA. The goal of this workshop is to provide a forum for continued open discussion between leading osteoarthritis experts in academia, industry, the non-profit sector, and government, with the ultimate goal of expediting the development of safe and effective treatments intended to provide long-term benefit in OA.
June 22, 2021; 10:00 AM - 5:00 PM ET FY 2021 Generic Drug Science and Research Initiatives Public Workshop
The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. The public workshop also fulfills FDA's commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Initiatives. June 23, 2021; 8:00 AM - 4:30 PM ET Working Together - Keeping Informed: FDA Medical Device Virtual Conference 2021
This one-day virtual conference, hosted by the Office of Medical Device and Radiological Health Operations, offers representatives of registered firms with the Food and Drug Administration (FDA) to learn about current FDA operations. June 23, 2021; 10:30 AM - 5:00 PM ET Webinar - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
FDA will host a webinar to share information and answer questions about the final guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. This guidance document provides the FDA's recommendations on testing to assess the safety and compatibility of medical devices in the MR Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. Ensuring the safety of patients who use magnetic resonance imaging (MRI) for disease diagnosis and health management is vital. June 24, 2021; 11:00 AM - 12:30 PM ET Registration is not required. 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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