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.
Comment Letter
Last updated: June 10, 2024
Dear Chair Heinrich, Chair Harris, Ranking Member Hoeven, and Ranking Member Bishop: As you begin to consider funding priorities for Fiscal Year 2025, we urge you to fund the Pediatric Device Consortia (PDC) Grant Program at the Office of Orphan Products Development (OOPD) at the Food and Drug Administration (FDA) at $7 million in Fiscal […]
Washington E-Newsletter
Last updated: May 9, 2024
On Feb. 20, the AANS and the CNS joined the Physician Clinical Registry Coalition in a letter to Food and Drug Administration Commissioner Robert M. Califf, MD, expressing support for using registry data as the agency develops guidance on using “real-world” data for medical device review. The letter was in response to draft guidance issued […]
Washington E-Newsletter
Last updated: May 9, 2024
Between April 1 and May 15, the Open Payments program, which collects information about financial relationships between health care providers and drug and device companies, allows providers to review their data for accuracy before it is publicly released in June. The AANS and the CNS encourage neurosurgeons to check the accuracy of their data and […]
Comment Letter
Last updated: June 10, 2024
VIA ELECTRONIC SUBMISSION Robert M. Califf M.D.Commissioner of Food and DrugsFood and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993 Re: Draft Guidance for Industry and Food and Drug Administration Staff—Use of Real World Evidence to Support Regulatory Decision-Making for Medical Devices (Docket No. FDA-2023-D-4395) Dear Commissioner Califf: The undersigned members of the Physician Clinical […]
Comment Letter
Last updated: June 10, 2024
Lauren K. RothAssociate Commissioner for PolicyFood and Drug Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20852 Submitted electronically via regulations.gov Re: Communications From Firms to Health Care Providers Regarding Scientific Information onUnapproved Uses of Approved/Cleared Medical Products: Questions and Answers Dear Associate Commissioner Roth: The Alliance of Specialty Medicine (the “Alliance”) represents more than 100,000 specialty […]
Letter of Support
Last updated: June 10, 2024
Subject: Protecting and Continuing Physician Education and Patient Care Act Dear Representatives Burgess and Bera, On behalf of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), representing more than 4,500 practicing neurosurgeons in the United States, we are pleased to endorse your legislation, the Protecting and Continuing Physician Education […]
Comment Letter
Last updated: June 10, 2024
Dear Chair Heinrich, Chair Harris, Ranking Member Hoeven, and Ranking Member Bishop: As you begin to consider funding priorities for Fiscal Year 2024, we urge you to fund the Pediatric Device Consortia (PDC) Grant Program at the Office of Orphan Products Development (OOPD) at the Food and Drug Administration (FDA) at $7 million in Fiscal […]
Medicare Advantage Data
Last updated: June 26, 2024
The Honorable Chiquita Brooks-LaSure AdministratorCenters for Medicare and Medicaid ServicesDepartment of Health and Human Services7500 Security BoulevardBaltimore, MD 21244-1850 Via Electronic Delivery Re: Step Therapy for Part B Drugs in Medicare Advantage Dear Administrator Brooks-LaSure, The undersigned organizations, representing millions of Medicare beneficiaries with life-threatening, complex, chronic conditions and/or the physicians who care for them, […]
Comment Letter
Last updated: June 26, 2024
RE: Solicitation for Public Comments on the Business Practices of Pharmacy Benefit Managers and Their Impact on Independent Pharmacies and Consumers (FTC-2022-0015-0001) To Whom It May Concern: The Alliance of Specialty Medicine (the “Alliance”) represents more than 100,000 specialty physicians and is deeply committed to improving access to specialty medical care through the advancement of […]
Comment Letter
Last updated: June 26, 2024
Angela K. Oliver, Executive SecretaryCenters for Disease Control and PreventionNational Center for Injury Prevention and Control4770 Buford Highway NEAtlanta, GA 30341 Attn: Docket No. CDC-2022-0024 Subject: Feedback on the CDC Clinical Practice Guideline for Prescribing Opioids Dear Ms. Oliver, The American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) appreciate the opportunity […]
