Advocacy - FDA Regulatory Policies, Processes and Funding Take Action Federal Advocacy State Advocacy Local Advocacy Protect Access & Innovation: Infographics & Resources CLSAPAC CLSA Capitol Connection Become an Advocate Policy & Advocacy News Letters, Testimony and Comments December 12, 2013HR 3742 Antibiotic Development to Advance Patient Treatment (ADAPT) Act July 18, 2013HR 2725 FDA Safety Over Sequestration (“S.O.S.”) Act July 3, 2013S 1413 FDA User Fee Protection Act May 15, 2013S 957 Drug Supply Chain Security Act of 2013 May 15, 2013S 959 Pharmaceutical Compounding Quality and Accountability Act of 2013 May 9, 2013HR 1919 Safeguarding America’s Pharmaceuticals Act of 2013 January 18, 2013HR 307 Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 January 1, 1970HR 3204 Drug Quality and Security Act May 25, 2018State Life Sciences Association Letter to FDA Regarding Compounded Drugs July 11, 2017Stakeholder Letter to FDA Commissioner Gottlieb Regarding Compounded Drugs – July 2017 November 29, 2016Stakeholder Support Letter for Rare Pediatric Disease Priority Review Voucher Reauthorization- – November 2016 November 14, 2016CLSA Comments on MDUFA Agreement in Principle – November 2016 September 27, 2016CLSA Comments on FDA Draft Guidance Relating to the Regulation of HCT/Ps – September 2016 July 18, 2016CLSA Comments on FDA Draft Guidance for Section 503A of the FDCA – July 2016 March 9, 2016CLSA Endorsement Letter – S. 1077, the Advancing Breakthrough Medical Devices for Patients Act of 2015 – March 2016 August 12, 2015CLSA Comments on MDUFA Reauthorization Negotiations (Docket No. FDA-2010-N-0389) – August 12 May 5, 2015Letter of Endorsement From State Life Sciences Associations In Support of Preventing User Fee Sequestration (FDA SOS Act) — May 2015 May 1, 2015Bipartisan House Letter to OMB Requesting Release of Biosimilars Guidance on Naming, Interchangeability — May 2015 March 30, 2015Biopharmaceutical Innovator Stakeholder Letter In Support of Pediatric Rare Disease Priority Review Voucher Program — March 2015 January 30, 2015CHI Letter to Reps. Anna Eshoo and Leonard Lance in Support of Bill to Prevent FDA User Fee Sequestration (FDA SOS Act) — January 2015 January 30, 2015CHI Letter to Reps. Gus Bilirakis and G.K. Butterfield in Support of Bill to Spur Rare Disease Therapy Innovation (OPEN Act) — January 2015 January 30, 2015CHI Letter to Rep. Roskam Supporting DISARM Act of 2015 — January 2015 September 19, 2014CHI Testimony to House Energy and Commerce Committee on Combating Antibiotic Resistance and Fostering New Drug Development — September 2014 February 3, 2014CHI Supports Stakeholder Letter to Federal Trade Commission (FTC) Urging Unique Names for Biosimilars — February 3, 2014 January 14, 2014CHI Thank You Letter to Rep. Anna Eshoo Regarding Omnibus Provision Unlocking FY13 FDA User Fees From Sequester — January 14, 2014 January 14, 2014CHI Thank You Letter to Rep Sam Farr Regarding Omnibus Provision Unlocking FY13 FDA User Fees From Sequester — January 14, 2014 January 7, 2014Congressional Letter to Appropriators Urging Release of FY13 FDA User Fees — January 7, 2014 December 7, 2013Coalition of 125 Rare Disease Organizations Letter of Endorsement for FDA SOS Act (H.R. 2725) — December 2013 November 18, 2013House Letter to Budget Conferees Urging User Fee Exemption from Sequestration (Rep. Mike Honda) — November 18, 2013 November 15, 2013Rep. Yoder-Led Letter to OMB Regarding FDA User Fee Sequester — November 15, 2013 November 14, 2013Multi-State Associations Letter to Budget Conferees Regarding FDA User Fee Sequester — November 14, 2013 November 13, 2013Bipartisan, Bicameral Letter to FDA from BPCIA Sponsors on Biosimilars Naming — November 13, 2013 – See more at: http://www.chi.org/fda-regulatory-policies/#sthash.k2NFHo3f.dpuf October 22, 2013OMB and Treasury Response to Eshoo-Led Bipartisan House Letter Regarding Sequestered FDA User Fees — October 28, 2013 October 21, 2013CHI & Biocom-Led Letter to Rep. Issa, Signed By Over 50 San Diego-Area Biopharmaceutical and Medical Technology Companies, Urging Support for the FDA SOS Act (HR 2725) — October 21, 2013 October 21, 2013CHI & Biocom-Led Letter to Rep. Hunter, Signed By Over 50 San Diego-Area Biopharmaceutical and Medical Technology Companies, Urging Support for the FDA SOS Act (HR 2725) — October 21, 2013 September 3, 2013CHI Statement In Support of S. 959, to Establish National Drug Tracing Standards and Strengthen Patient Protections — September 2013 August 1, 2013Eshoo-Led Bipartisan House Letter to Treasury and OMB Regarding Sequestered FDA User Fees — August 1, 2013 July 9, 2013CHI Letter to Reps. Jackie Speier and Mike Burgess in Support of Legislation to Ensure Patient Access to Personalized Medicine Diagnostics — July 9, 2013 June 12, 2013CHI Letter Supporting Bill to End FDA User Fee Sequester (Rep. Anna Eshoo) — July 12, 2013 June 11, 2013CHI Comments to FDA Regarding 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device — June 11, 2013 May 24, 2013CHI and California Biomedical Industry Leaders Urge Congress to Take Action on FDA User Fees for FY2014 — May 24, 2013 May 14, 2013CHI Statement In Support of H.R. 1919, to Establish National Drug Tracing Standards and Strengthen Patient Protections — May 14, 2013 March 19, 2013CHI Statement Regarding Fiscal Year 2014 FDA Appropriations, Submitted to House Appropriations Committee — March 19, 2013
