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21st Century Cures: A Call to Action

PhRMA  |  Speeches & Communication

There may be no higher public health priority than accelerating the ability of researchers to navigate the long and costly discovery and development process to deliver new medicines and potential cures to patients in need.
https://www.phrma.org/public-communication/21st-century-cures-a-call-to-action

PhRMA ITC Testimony - April 23, 2015

PhRMA  |  Speeches & Communication

Read the related blog post on The Catalyst:India’s IP Policies: Still Much Room for Improvement...
https://www.phrma.org/public-communication/phrma-itc-testimony-april-23-2015

PhRMA Comments on the Reauthorization of the Prescription Drug User Fee Act (PDUFA VI)

PhRMA  |  Speeches & Communication

PhRMA is pleased to participate in today’s public stakeholder meeting and appreciates the opportunity to respond to the FDA’s request for comments on the overall performance of PDUFA V.
https://www.phrma.org/public-communication/phrma-comments-on-the-reauthorization-of-the-prescription-drug-user-fee-act-pdufa-vi

PhRMA Remarks On PTO's 2014 Guidance on Patent Eligibility

PhRMA  |  Speeches & Communication

PhRMA appreciates the PTO’s outreach to stakeholders regarding the matters discussed in the Interim Eligibility Guidance, and the PTO’s consideration of both PhRMA’s comments and the comments of others during this process. The Interim Eligibility Guidance is a substantial improvement over the PTO...
https://www.phrma.org/public-communication/comments-of-phrma-regarding-the-pto-s-2014-interim-guidance-on-patent-subject-matter-eligibility

Brief of PhRMA as Amicus Curiae in Support of Petitioner

PhRMA  |  Speeches & Communication

PhRMA seeks to advance public policies that foster innovation and encourage its members’ investments.
https://www.phrma.org/public-communication/brief-of-phrma-as-amicus-curiae-in-support-of-petitioner

Embracing 21st Century Information Sharing: Defining a New Paradigm for the FDA and Communications with Health Care Professionals

PhRMA  |  Blog Post

Permit Manufacturers to Use Robust Disclosures/Disclaimers to Disclose Limitations of Data Rather Than Prohibit Certain Health Care Communications – There must be precautions in place to ensure that medical communications remain data-driven and transparent about risks and/or limitations of scientific understanding.
http://catalyst.phrma.org/embracing-21st-century-information-sharing-defining-a-new-paradigm-for-the-fda-and-communications-with-health-care-professionals

21st Century Cures: An Update on the President’s PCAST Report

PhRMA  |  Speeches & Communication

The Pharmaceutical Research and Manufacturers of America (PhRMA) believes that the challenges affecting the ability to provide life-saving and life-enhancing new medicines to patients in an efficient and timely manner are significant, and addressing them will require the involvement of and partne...
https://www.phrma.org/public-communication/21st-century-cures-a-update-on-the-president-s-pcast-report

Ethicon Endo-Surgery, Inc. vs. Covidien LP

PhRMA  |  Speeches & Communication

When the members of PhRMA and BIO invest in the research to develop innovative technology, they do so with the expectation that the intellectual property arising from their efforts will be protected by the just administration of United States patent law. PhRMA and BIO seek to advance policies tha...
https://www.phrma.org/public-communication/ethicon-endo-surgery-inc-vs-covidien-lp

PhRMA comments to FDA on Biosimilar Labeling

PhRMA  |  Speeches & Communication

PhRMA is pleased to provide comments on the Food and Drug Administration's (FDA) Draft Guidance for Industry: Labeling for Biosimilar Products. PhRMA supports the Draft Guidance in several respects, including the proposed recommendation that biosimilar labeling should state that the product has b...
https://www.phrma.org/public-communication/phrma-comments-to-fda-on-biosimilar-labeling

Avalere Insights on Latest Evidence Communication Research

PhRMA  |  Blog Post

Our research also found that manufacturers generally believe that additional guidance to interpret and apply FDAMA 114 would be helpful and would encourage greater generation and communication of economic, comparative, and real-world evidence.
http://catalyst.phrma.org/avalere-insights-on-latest-evidence-communication-research

Public Supports Coverage of Personalized Medicine

Chartpack  |  From Our Network

In a recent survey, nearly two-thirds of individuals surveyed believe payers should cover personalized medicine tests and treatments....
http://chartpack.phrma.org/personal-medicines-in-development-chartpack/benefiting-patients-and-the-health-care-system/public-supports-coverage-of-personalized-medicine

PhRMA Response to Colombia’s Decision to Enforce a Declaration of Public Interest

PhRMA  |  Press Release

“The enforcement of a declaration of public interest as a mechanism to impose superfluous price controls sets a harmful global precedent, undermining the incentives that enable high-risk research and development investments in life-saving medical innovation and a host of other cutting-edge industries.
https://www.phrma.org/press-release/phrma-response-to-colombias-decision-to-enforce-a-declaration-of-public-interest

PhRMA Statement on FDA Communications Hearing

PhRMA  |  Press Release

Washington, D.C. (November 9, 2016) — Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued the following statement: “As the U.S. health care system evolves to become increasingly focused on va...
https://www.phrma.org/press-release/phrma-statement-on-fda-communications-hearing

ICYMI - The Economists’ Voice: Are biopharmaceutical budget caps good public policy?

PhRMA  |  Blog Post

In case you missed it, a recent article in The Economists’ Voice examines how assessing the value of medicines using budget caps would impede patient access and chill biopharmaceutical ...
http://catalyst.phrma.org/icymi-the-economists-voice-are-biopharmaceutical-budget-caps-good-public-policy

Comments of the Pharmaceutical Research and Manufacturers of America on the PTO’s Request for Comments on Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board

PhRMA  |  Speeches & Communication

The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates the opportunity to submit comments in connection with the Patent and Trademark Office‘s (PTO) or Office Request for Comments on Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board (PTA...
https://www.phrma.org/public-communication/comments-of-the-pharmaceutical-research-and-manufacturers-of-america-on-the-pto-s-request-for-comments-on-amendments-to-the-rules-of-practice-for-trials-before-the-patent-trial-and-appeal-board

PhRMA Comment: Draft Guidance for Industry and Review Staff: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities

PhRMA  |  Speeches & Communication

The Pharmaceutical Research and Manufacturers of America's comments in response to FDA’s Draft Guidance for Industry and Review Staff entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities/Questions and Answers”. – Questions and Answers, Docket No.
https://www.phrma.org

Modernizing FDA regulations to advance a value-driven health care system

PhRMA  |  Blog Post

public hearing, or see the .regulations.gov/document?
http://catalyst.phrma.org/modernizing-fda-regulations-to-advance-a-value-driven-health-care-system

Prescription Drug Misuse, Abuse & Disposal

PhRMA  |  From PhRMA

The Community Anti-Drug Coalitions of America (CADCA), which supports local efforts to combat drug abuse in communications nationwide.
https://www.phrma.org/advocacy/safety/prescription-misuse-abuse

Fact Check Friday: Communications with Payers

PhRMA  |  Fact Sheet

In this Fact Check Friday, the myth is all about communication with payers.
https://www.phrma.org/fact-sheet/fact-check-friday-communications-with-payers

PhRMA Statement on United States and China Public-Private Partnership on Healthcare

PhRMA  |  Press Release

PhRMA Internet Address: www.phrma.org For information on stories of hope and survival, visit: http://sharingmiracles.com/ For information on how innovative medicines save lives, visit: www.innovation.org For information on the Partnership for Prescription Assistance, visit: www.pparx.org For more information on public health emergencies, visit: www.rxresponse.org For information on the danger of imported drugs, visit: www.buysafedrugs.info
https://www.phrma.org/press-release/phrma-statement-on-united-states-and-china-public-private-partnership-on-healthcare

PhRMA Response to Colombia’s Issuance of a Declaration of Public Interest

PhRMA  |  Press Release

“The issuance of a declaration of public interest as a mechanism to impose superfluous price controls sets a harmful global precedent, undermining the incentives that enable high-risk research and development investments in life-saving medical innovation and a host of other cutting-edge industries.
https://www.phrma.org/press-release/phrma-response-to-colombia-s-issuance-of-a-declaration-of-public-interest

Fact Check Friday: Biopharmaceutical company communications with payers

PhRMA  |  Blog Post

Read more about PhRMA’s policy solutions regarding responsible communications with payers here.
http://catalyst.phrma.org/fact-check-friday-biopharmaceutical-company-communications-with-payers

PhRMA & BIO release joint principles on communications with health care professionals and payers

PhRMA  |  Blog Post

Learn more about communications with health care professionals and payers here.
http://catalyst.phrma.org/phrma-bio-release-joint-principles-on-communications-with-health-care-professionals-and-payers

Comments of the Pharmaceutical Research and Manufacturers of America on the PTO’s Request for Comments on a Proposed Pilot Program Exploring an Alternative Approach to Institution Decisions in Post Grant Administrative Reviews

PhRMA  |  Speeches & Communication

The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates the opportunity to submit comments in connection with the Patent and Trademark Office’s (PTO or Office) Request for Comments on a Proposed Pilot Program Exploring an Alternative Approach to Institution Decisions in Post ...
https://www.phrma.org/public-communication/comments-of-the-pharmaceutical-research-and-manufacturers-of-america-on-the-pto-s-request-for-comments-on-a-proposed-pilot-program-exploring-an-alternative-approach-to-institution-decisions-in-post-grant-administrative-revi

Collaborations Between Public and Private Sector Are Critical to Advance Alzheimer’s Research

PhRMA  |  Press Release

Find PhRMA Online: Website – http://www.phrma.org Facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMA and www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress  For information on how innovative medicines save lives, visit: http://www.innovation.orgFor information on the Partnership for Prescription Assistance, visit: http://www.pparx.orgFor information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org
https://www.phrma.org/press-release/collaborations-between-public-and-private-sector-are-critical-to-advance-alzheimer-s-research

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