The AANS/CNS Drugs and Devices Committee is actively engaged with the Food and Drug Administration (FDA) and other scientific, governmental, clinical and industry representatives to provide neurosurgical expertise on drugs, devices and biologics used to treat patients and to foster innovation and patient safety. These activities include recommending neurosurgeon experts to serve on the FDA Advisory panels, providing input on FDA Guidance Documents and testimony at panel meetings, as appropriate. In addition, organized neurosurgery is an official partner with the FDA's Network of Experts program to provide rapid clinical assistance to FDA reviewers. The AANS and CNS continue to advocate policies that will decrease the regulatory burden for medical-device innovation and ensure patient access to new and improved medical technology.
Letters
RE: Support for the “Medical Product Communications Act of 2017” (H.R. 1703) Dear Congressman Griffith: The Alliance of Specialty Medicine (the “Alliance”) represents more than 100,000 specialty physicians. TheAlliance is […]
Article
Published: April 26, 2017
Introduction to FDA’sDivision of Neurological andPhysical Medicine DevicesAANS Abbreviated Slide DeckComing SoonAANS FDA Session 2018 … Read full article here
Article
Published: April 17, 2017
Promote safe storage and disposalof opioids and all medications. The American Medical Association Task Forceto Reduce Opioid Abuse strongly supportsthe education and awareness of physicians,patients, policymakers, and other keystakeholders regarding […]
Letters
Published: March 31, 2017
Dear Chairman Alexander and Ranking Member Murray: The undersigned members of the Alliance of Specialty Medicine write to express our support for therecent appointment of Scott Gottlieb, MD to Commissioner […]
Article
Published: March 17, 2017
Physician-Directed Applications Physician-directed applications, also known as “off-label”1 uses, are an integral component ofthe art and science of medical practice, particularly for specialty physicians. Using medicalexpertise and judgment, physicians may […]
Article
Published: February 24, 2017
Perspective of a Neurosurgeon who treats Stroke Adnan H. Siddiqui, MD, PhDProfessor & Vice-Chairman Department of NeurosurgeryDirector Neurosurgical Stroke Service, Kaleida HealthChief Medical Officer, Jacobs Institute Presenting endorsed statement fromAmerican […]
Article
Published: February 21, 2017
2017 Health Policy Principles The Alliance of Specialty Medicine advocates for sound federal health care policy that fosterspatient access to the highest quality specialty care and improves timely access to […]
Article
Published: February 10, 2017
AANS and CNS Statement on the Confirmation of Rep. Tom Price to Lead HHSNeurosurgeons Commend Senate for Approving Dr. Price’s Nomination as Nation’s Top Health Official Washington, DC—The American Association […]
Letters
Published: December 1, 2016
RE: Support of the 21st Century Cures Legislation Dear Leader McConnell, Leader Reid, Chairman Alexander, and Ranking Member Murray: The Alliance of Specialty Medicine writes in support H.R. 34, the […]
Letters
Published: December 1, 2016
RE: 21st Century Cures Act Dear Majority Leader McConnell and Minority Leader Reid: The undersigned members of the Physician Clinical Registry Coalition strongly support theprovisions of the 21st Century Cures […]
Letters
Published: November 29, 2016
SUBJECT: 21st Century Cures Legislation Dear Speaker Ryan and Leader Pelosi: On behalf of the American Association of Neurological Surgeons (AANS) and Congress of NeurologicalSurgeons (CNS), we are writing to […]
Article
Published: November 9, 2016
Statementof theAmerican Association of Neurological SurgeonsCongress of Neurological Surgeonsbefore theFood and Drugs AdministrationPublic Hearingon the Subject ofManufacturer Communications ofPhysician-Directed Uses of Approved Medical ProductsNovember 9, 2016 My name is William […]
Letters
Published: August 11, 2016
Dear Speaker Ryan, On behalf of the undersigned medical specialty organizations, we applaud you for yourcommitment to move a compromise 21st Century Cures bill in the fall. As Senate MajorityLeader […]
Letters
To the Members of the United States Senate and the United States House of Representatives: The undersigned organizations representing health care providers write to express our appreciation forthe bipartisan, bicameral […]
Letters
Dear Dr. Barrasso: On behalf of the undersigned organizations, we are writing to express our strong support for S. 2978, the“Protect Continuing Physician Education and Patient Care Act,” which would […]
Letters
Subject: Clinical Considerations for Investigational Device Exceptions (IDEs) forNeurological Devices Targeting Disease Progression and Clinical Outcomes;Draft Guidance Document for Industry and FDA Staff Dear Dr. Pena: On behalf of the […]
Article
Help save lives:Increase access to naloxone For more than 40 years, naloxone has beensaving the lives of people who overdose onan opioid. With the United States in the midstof an […]
Article
With 44 Rx opioid related deaths aday, what can onephysician do? More than you might think. Registering for and using state prescription drugmonitoring programs (PDMP), for example, can be an […]
Letters
Published: December 11, 2015
The Honorable Todd YoungU.S. House of RepresentativesWashington, DC 20515 Subject: Removing Barriers to Clinical Research Act Dear Representative Young, On behalf of the American Association of Neurological Surgeons (AANS) and […]
Article
Published: November 30, 2015
FDA Stroke Devices Meeting, October 6, 2015Breakout Session Questions Follow Up from AANS/CNS JointSection on Cerebrovascular Neurosurgery Attendees The consensus comments below were developed by the members of the American […]
Article
Published: October 19, 2015
Overview On October 6, 2015, the Centers for Medicare and Medicaid Services (CMS) released its final rule, Medicare andMedicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful […]
Letters
Published: October 15, 2015
SUBJECT: Medical Controlled Substances Transportation Act of 2015 Dear Messrs. Goodlatte, Conyers, Sensenbrenner and Ms. Jackson Lee: On behalf of the American Association of Neurological Surgeons (AANS) and Congress of […]
Letters
Published: October 15, 2015
SUBJECT: Medical Controlled Substances Transportation Act of 2015 Gentlemen: On behalf of the American Association of Neurological Surgeons (AANS) and Congress of NeurologicalSurgeons (CNS), we want to provide our support […]
Letters
Published: October 15, 2015
SUBJECT: Medical Controlled Substances Transportation Act of 2015 Dear Rep. Sessions, On behalf of the American Association of Neurological Surgeons (AANS) and Congress of NeurologicalSurgeons (CNS), we want to provide […]
Letters
Dear Representative: The Alliance of Specialty Medicine urges you to vote “yes” on the House passage of H.R. 6, the “21st Century CuresAct.” The Alliance is a coalition of national […]
