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
Published: November 6, 2024
RE: The Biosimilar Red Tape Elimination Act (S.2305) Dear Majority Leader Schumer, Speaker Johnson, Minority Leader McConnell, and Minority Leader Jeffries: The Alliance of Specialty Medicine (Alliance) is a coalition […]
Letters
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 […]
Letters
Published: February 24, 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M.D.Commissioner of Food and DrugsFood and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993 Re: Draft Guidance for Industry and Food and Drug Administration […]
Letters
Published: December 21, 2023
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 […]
Letters
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 […]
Letters
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 […]
Medicare Advantage Data
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 […]
Letters
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 […]
Letters
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 […]