Group Comment Letter to FDA on Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products
Dear Commissioner Hahn,
The undersigned groups share the Food and Drug Administration’s (FDA) deep commitment to the development of a robust biosimilars market and appreciate the Agency’s work to develop an efficient approval pathway for biosimilars to bring savings and access to America’s patients. As such, we support the approach outlined in the “Clinical Immunogenicity Considerations from...
Learn MoreComments of the Healthcare Supply Chain Association (HSCA) on FDA Request for Comments on Ethylene Oxide Sterilization of Medical Devices
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Food and Drug Administration (FDA) regarding the use of Ethylene Oxide (EtO) to sterilize medical devices.
HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing and purchasing partners to virtually all of America’s 7,000+...
Learn MoreHSCA Submits Comments to ANSI on Healthcare Supply Chain Data Standards to Help Improve Accuracy, Efficiency, and Patient Safety
Washington, DC (November 26, 2019) – The Healthcare Supply Chain Association (HSCA) Committee for Healthcare eStandards (CHeS) today submitted comments to the American National Standards Institute’s (ANSI) Accredited Standards Committee (ASC) X12 supporting the Committee’s recommendation to include medical device identifiers in the healthcare electronic claim form.
The vast majority of...
Learn MoreJoint Letter of Support for the MEDS Act
Dear Senator Collins and Senator Smith,
The undersigned organizations are writing in support of S.2723 – The Mitigating Emergency Drug Shortages (MEDS) Act. Drug shortages have been on the rise for several years, with an estimated 210 drugs currently at risk or not readily available for U.S. hospitals, according to the national database maintained by the American Society of Health System...
Learn MoreHSCA Applauds Senators Collins and Smith for Bipartisan Legislation to Prevent and Mitigate Drug Shortages
Washington, DC (October 30, 2019) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement applauding Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN) and announcing HSCA’s support for The Mitigating Emergency Drug Shortages (MEDS) Act:
“HSCA and its member group purchasing organizations (GPOs) applaud Senators Collins and...
Learn MoreHSCA Statement on FDA Drug Shortages Task Force Report
Washington, DC (October 29, 2019) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement regarding the recent report by the Food and Drug Administration (FDA) Drug Shortages Task Force on drug shortages:
“Ongoing critical prescription drug shortages jeopardize patient access to essential medications. As FDA has noted, the causes...
Learn MoreComments of the Healthcare Supply Chain Association (HSCA) on Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments on the U.S. Drug Enforcement Administration’s (DEA or Agency) proposed aggregate production quotas for Schedule I and II controlled substances. HSCA supports DEA’s efforts to support interagency collaboration around controlling opioid diversion. We are concerned, however, that absent...
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