September 13, 2017 – PASS Coalition Testifies Before Congress Regarding the Need for Innovative Sunscreen Products
Testimony of Michael Werner, JD Partner, Holland & KnightOn behalf of The Public Access to SunScreens (PASS) Coalition House Committee on Energy and Commerce Subcommittee on HealthSeptember 13, 2017 Good morning, Chairman Burgess, Ranking Member Green, and members of the Subcommittee, my name is Michael Werner. I am a partner at the law firm of […]
September 13, 2017 – PASS Coalition Testifies Before Congress Regarding the Need for Innovative Sunscreen Products
Given the lack of new and innovative sunscreen ingredients in the United States, the PASS Coalition has worked tirelessly with Congress and the FDA to reform the OTC monograph system and ensure a practical path forward for new sunscreen ingredient applications. The PASS Coalition’s Policy Advisor, Michael Werner, JD, testified before the House Energy and […]
FDA’s Final Guidance Regarding Over-the-Counter Sunscreen Safety and Effectiveness Continues to Fall Short While Two Year Anniversary of Sunscreen Innovation Act Becoming Law Looms
For Immediate Release: November 22, 2016 Contact: Aimee Steel Lubin, aimee.lubin@hklaw.com / 202-828-1895 (Washington, D.C.) – Today the Food and Drug Administration (FDA) published “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data – Guidance for Industry,”” as required by the Sunscreen Innovation Act (Public Law 113 – 195). The Public Access to SunScreens (PASS) […]
Comment from Public Access to Sun Screens Coalition
February 22, 2016 Kristen Hardin Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 22, Rm. 5443 Silver Spring, MD 20993-0002 RE: Public Comments on Draft Guidance “Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry” [Docket No. FDA-2015-D-4021] Dear Ms. Hardin, The following are the comments of […]
Comment from Public Access to Sun Screens Coalition
February 22, 2016 Kristen Hardin Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 22, Rm. 5443 Silver Spring, MD 20993-0002 RE: Public Comments on Draft Guidance “Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry” [Docket No. FDA-2015-D-4021] Dear Ms. Hardin, The following are the comments of […]
FDA’s Final Guidance Regarding Over-the-Counter Sunscreen Safety and Effectiveness Continues to Fall Short While Two Year Anniversary of Sunscreen Innovation Act Becoming Law Looms
For Immediate Release: November 22, 2016 Contact: Aimee Steel Lubin, aimee.lubin@hklaw.com / 202-828-1895 (Washington, D.C.) – Today the Food and Drug Administration (FDA) published “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data – Guidance for Industry,”” as required by the Sunscreen Innovation Act (Public Law 113 – 195). The Public Access to SunScreens (PASS) […]
PASS Coalition Submits Comments in Response to FDA’s Draft Guidance on OTC Sunscreens’ Safety and Effectiveness
For Immediate Release: February 22, 2016 Contact: Aimee Steel Lubin, aimee.lubin@hklaw.com / 202-828-1895 (Washington, D.C.) — The Public Access to SunScreens (PASS) Coalition submitted comments in response to the FDA’s Draft Guidance “Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry” (the Guidance) published in the Federal Register on November 23, 2015, as required […]
PASS Coalition Commends Dr. Robert Califf for His Commitment to Work to Ensure New Sunscreens Get to Market
On the Brink of Year Anniversary of the Sunscreen Innovation Act Becoming Law, Nothing Has Changed Except Rising Melanoma Rates (Washington, D.C.) —The Public Access to SunScreens (PASS) Coalition today commended Dr. Robert Califf on his public commitment to work with Senator Johnny Isakson (R-GA), other congressional leaders, and stakeholders to ensure new sunscreens […]
FDA’s Announcement on Ecamsule and Enzacamene Applications Demonstrates Clear Disregard for Increased Rates of Melanoma, Public’s Demand for Latest Sunscreen Technology.
Like the Six previously Pending Ingredients Ecamsule and Enzacamene Will Continue to be Held Hostage by the FDA Today, the Public Access to SunScreens (PASS) Coalition released a statement regarding FDA’s recent announcement of two sunscreen ingredient applications, ecamsule and enzacamene. Michael Werner, policy advisor to the PASS Coalition stated, “Today’s action taken by the […]
FDA’s Announcement on Ecamsule and Enzacamene Applications Demonstrates Clear Disregard for Increased Rates of Melanoma, Public’s Demand for Latest Sunscreen Technology.
Like the Six previously Pending Ingredients Ecamsule and Enzacamene Will Continue to be Held Hostage by the FDA Today, the Public Access to SunScreens (PASS) Coalition released a statement regarding FDA’s recent announcement of two sunscreen ingredient applications, ecamsule and enzacamene. Michael Werner, policy advisor to the PASS Coalition stated, “Today’s action taken by the […]