|FDA and NTEU agree to work together regarding|
mandatory foreign inspection assignments.
|National Treasury Employees Union (NTEU)||ORA|
|Partnership between FDA and FDAAA on future specific undertakings that are considered beneficial for both organizations and are directly related to FDA's mission.||FDA Alumni Association|
OEA Lawrence Bachorik (301) 796-8643
|FDA and BIG will work together to address issues affecting children, families, and communities within each organizations jurisdiction through educational campaigns-food safety.||Blacks in Government (BIG)||OC|
|225-09-0013||Establishes a cooperative public education program between The Food and Drug Administration (FDA),Waterfront Media to provide consumers with better information and timely content concerning public health and safety topics, including emerging safety issues and product recalls.||Waterfront Media|
|225-10-0021||Defines the framework in which the FDA will provide publicly available content to be used in health professional informational, educational, and training programs that will be run by WebMD LLC ("WebMD") and Medscape, LLC ("Medscape"), an entity accredited by ACCME, ANCC, and the ACPT to provide continuing professional education to physicians, nurses and pharmacists, respectively. Amended to extend expiration date.||Medscape, LLC and WebMD||OC/OEA|
|225-11-0013||Establishes a framework between The United States Food and Drug Administration (FDA) and CHDI Foundation, Inc. (CHDI) to share interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research.||CHDI Foundation||CDER|
Establishes a cooperative public education program between The Food and Drug Administration (FDA) and The HealthCentral Network Inc. to extend the reach of FDA Consumer Health Information and provide consumers with better information and timely content concerning public health and safety topics, including emerging safety issues and product recalls.
|The Health Central Network|
|225-11-0017||Defines the framework for collaboration between CDER and FDA and the Institute for Safe Medication Practices. The purpose of the collaboration is to improve the safety of the American public when using CDER-regulated products. Amendment 1 to extend timeframe. Amendment 2 to clarify point of contact for conveyance of information.||Institute for Safe Medication Practices||CDER|
|225-11-0021||Establishes a strategic framework for collaboration between FDA and the Uppsala Monitoring Centre (UMC) and outlines the process for collaborative sharing of public information between the FDA and the UMC for carrying out their common goal to improve the global safety and effective use of medicinal products.||Uppsala Monitoring Centre||CDER|
Gerald Dal Pan
|225-11-0023||Establishes the cooperative efforts between FDA and NABP to enhance enforcement of applicable statutes and regulations, including the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301et seq., and its implementing regulations, and state statutes and regulations, to protect patients from|
harm resulting from illegal domestic prescribing and dispensing of prescription drugs on the Internet.
|National Association of Boards and Pharmacy|
|225-11-0025||Establishes terms to promote shared interests in various programs such as collaborative education and research.||American College of Gastroenterology|
CDER, Donna Griebel (301) 796-4153
|225-11-0026||FDA and the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) collaborate to promote scientific progress through exchange of scientific capital in a Gastroenterology Drug Development Fellowship Training and Research Program.||North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN)||CDER|
Donna J. Griebel, MD
|225-11-0029||The FDA and MedStar Health collaborate to develop training programs for the FDA and potentially other government agencies, the healthcare products industry and healthcare professionals and users of medical products in the broad areas of medicine, health sciences, nursing, biomedical engineering, systems engineering, human factors, simulation and other product evaluation methods, patient safety, project management, business administration, and health policy.||MedStar Health|
Establishes the terms for collaboration to promote shared interests, which can be pursued through a variety of programs including collaborative research, public outreach, extension activities, cooperative international initiatives, and disciplinary training.
|225-12-0008||This document sets forth a framework for an alliance between the FDA and SOT. It is intended to describe their combined strengths, resources, and proximity for stimulating innovation in toxicity testing, regulatory science, ethics, and education and training.||Society of Toxicology (SOT)||Jesse Goodman, MD|
|225-12-0014||Defines the framework for collaboration between CDER of FDA and the Institute for Safe Medication Practices||Institute for Safe Medication Practices||CDER|
Gerald J. DalPan
|225-12-0016||Establishes the terms for collaboration to promote shared interests between FDA and ImproveCareNow||ImproveCareNow||CDER|
Donna J. Griebel
|225-13-0021||Establishes terms for collaboration to promote developing innovative health technologies that could benefit the public health.||X Prize Foundation|
Murray Sheldon, MD
|225-12-0025||Collaborate and involve a consortium of various stakeholders including academic, research and clinical stakeholders, advocacy groups, industry, international partners, and others who may collaborate to advance regulatory science; and foster biomedical and biotechnology innovations, in personalized medicine, health information technology, data mining analytics, post-market safety surveillance, comparative safety and efficacy analysis, and international harmonization to support FDA's mission.||The IV2 Alliance, Inc.||OC Walter Harris||05-01-2013||04-30-2018|
Establishes the terms for collaboration to promote these shared interests education and research, and mutual exchange of training and research expertise in clinical pharmacology and translational science.
|American Society of Nephrology||CDER, Patrick Archdeacon (301) 796-3952||09-06-2012||Indefinite|
|225-12-8000||Promoting scientific progress through knowledge exchange of scientific capital in pharmacology and translational research.||The Systems Biology Institute||CDER Darrell Abernethy 301) 796-5008||06-11-2012||06-09-2018|
|Defines the working arrangements between FDA and USPC in regards to the review revisions to compendial requirements for drugs.||U.S. Pharmacopeial Convention, Inc. (USPC)||CDER|
|To foster and improve the sanitation and quality of shellfish in the U.S.||Interstate Shellfish Sanitation Conference (ISSC)||CFSAN|
|CFP and FDA agree to establish a working relationship to address issues on food safety in order to implement the recommendations adopted at Conference meetings.||Conference for Food Protection (CFP)||ORA|
|Evaluating test kits for detecting animal drug residues in milk||AOAC||CVM|
Collaborate on developing new methods to evaluate the toxicity of substances regulated by the FDA; improving the pathway for the review and approval of regulated substances; facilitating the FDA’s engagement with scientists from academia, government and industry on regulatory science questions that impact drug development and safety prediction; sharing information that is in the public domain and considered non-confidential; and publicly disseminating scientific knowledge to help bring safe and effective products to market.
ILSI Health and Evironmental Sciences Institute
Establish framework for collaboration between FDA and Washington Adventist Hospital including collaborative research, public outreach, extension activities, training, and exchange of medical professionals and staff by the two organizations.
|Washington Adventist Hospital|
Eileen Parish, M.D.,
Office of the Chief Scientist
|225-14-012||Collaborative health professional training, outreach, and research initiatives.||American Nurses Association|
Teresa Rubio (301) 796-5113
|May 17, 2013||Indefinite|
|225-14-0019||Encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices.||National Health Information Sharing and Analysis Center, Inc.||Suzanne Schwartz, M.D., MBA (301) 796-6937||August 26, 2014||August 25, 2019|
|225-14-8000||Promote awareness and understanding of gender medicine and science of sex-based differences.||Karolinska Institutet|
Helen J. Barr, MD
|225-14-023||Promoting scientific progress, furthering public policy efforts, and translating innovation and discoveries into practice in the areas of medical and biological engineering.||American Institute for Medical and Biological Engineering AIMBE|
Anindita Saha 301-796-2537
|225-14-024||Promote and Provide FDA Consumer Updates on public health and safety messages on emerging issues and product recalls to consumers.||Healthline.com|
Sets forth principles and guidelines by which the parties intend to engage in a cooperative public education program. It is the parties’ intent to promote and increase the use of health knowledge, skills, and practices by the general population in its patterns of daily living.
|The National Forum for Heart Disease and Stroke Prevention|
OEA/OC Helene Clayton-Jeter 301-796-8452
Engage in sharing of pre-decisional nonpublic compliance and enforcement policy information is intended to improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements.
|National Association of Attorneys General|
|Promoting scientific progress through the exchange of scientific capital to develop innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety.||Critical Path Institute||CDER ShaAvheree Buckman-Garner, 301-796-2600||04-09-2015||Indefinite|
|225-16-002||Collaborate in educating the public about health issues||National Consumers League||CDER Kimberly Rawlings 301-796-3818||11-10-2015||11-09-2018|