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PPTA Applauds the Florida Legislature for Preserving Medicaid Patient Access to Blood Clotting Factor
May 17, 2011
(May 17, 2011) The Plasma Protein Therapeutics Association commends the Florida legislature for allowing Medicaid recipients to continue to receive their clotting factor and the overlay services through the agency's hemophilia disease management program, rather than forcing them to switch to a managed care plan for their therapeutic needs.
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PPTA Commends Congress and President Obama for Repealing the 1099 Tax-reporting Provision
April 15, 2011
(April 15, 2011) The Plasma Protein Therapeutics Association (PPTA) applauds Congress and President Obama for preserving patient access to safe and effective plasma protein therapies by repealing the 1099 tax-reporting provision.
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New Spanish Language Translations Available on PPTA Websites
April 14, 2011
(April 14, 2011) – The Plasma Protein Therapeutics Association (PPTA) recently updated the Association’s global website and its website on plasma donation with Spanish language translations of some materials posted online to better serve consumers.
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PPTA Hosts Congressional Staff Briefing
April 4, 2011
(April 4, 2011) PPTA collaborated with the patient community to host a Congressional staff briefing focused on the uniqueness of plasma protein therapies and the importance of access.
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PPTA Statement: Proven Safety of Human Albumin
March 7, 2011
(March 7, 2011) Statements in the international media have described the events resulting from the retraction by several leading medical journals of a large number of articles describing scientific studies by a German physician, Joachim Boldt. Boldt was dismissed from his position as head of anesthesia in the Klinikum Ludwigshafen in the state of Rheinland-Pfalz in Germany in November 2010, following initial findings by a leading anesthesia journal that a paper describing a clinical study which Boldt published in the journal had been fabricated.
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New German Language Video On Plasma Donation Available
March 2, 2011
(March 2, 2011) – Anyone curious about what to expect as a plasma donor and how plasma contributes to lifesaving medicines can now learn about the process thanks to a new German language DVD from the Plasma Protein Therapeutics Association (PPTA).
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PPTA Recognizes Rare Disease Day
February 28, 2011
(Feburary 28, 2011) Today, the Plasma Protein Therapeutics Association (PPTA) is proud to support the National Organization for Rare Disorders (NORD) in raising awareness for the needs of individuals coping with rare diseases by joining the organization in recognizing Rare Disease Day.
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PPTA Invited By MHLW To Give Presentation in Japan
February 9, 2011
(February 9, 2011) - The Plasma Protein Therapeutics Association (PPTA) was invited by the Japanese Ministry of Health, Labor and Welfare (MHLW) to present its opinion to a panel that is looking into the future supply of plasma protein therapies into Japan.
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New Video on Plasma Donation Available
January 28, 2011
(January 28, 2011) – Anyone curious about what to expect as a plasma donor and how plasma contributes to lifesaving medicines can now learn about the process thanks to a new DVD from the Plasma Protein Therapeutics Association (PPTA). “Becoming a Plasma Donor,” details the safety and eligibility steps required to become a committed plasma donor at one of the 400-plus U.S. Food and Drug Administration-licensed and International Quality Plasma Program-certified plasma collection centers in the United States. The 10 minute video illustrates how critically important plasma donors are to the production of safe and effective therapies that help individuals coping with rare, chronic, life-threatening diseases.
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Letter to Stakeholders re: IVIG (January 27, 2011)
January 27, 2011
Looking back on 2010, the PPTA North America Supply Data program has served the patient community well by providing aggregate historical data that depicts a snapshot of U.S. monthly distribution of immune globulins, albumin (5% and 25%), as well as plasma-derived FVIII and recombinant FVIII. A graphical depiction of U.S. distribution is publicly available on our web site (www.pptaglobal.org). PPTA makes this data public in an effort to provide confidence to consumers who rely upon access to plasma protein therapies to maintain their quality of life and also to inform policymakers.
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PPTA Letter to Stakeholders re: U.S. Data Distribution Program (Dec 9, 2010)
December 9, 2010
As you know, on November 30, PPTA informed all Stakeholders that the Association was temporarily suspending operation of its data system, which provides timely information on the available supply in North America for immune globulin, albumin and factor VIII products. This follow-up communication is to inform you that this temporary suspension has now ended.
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PPTA Letter to Stakeholders re: U.S. Data Distribution Program (Nov 30, 2010)
December 8, 2010
PPTA is proud to have a data system since 1998 that provides timely information on the available supply in North America for immune globulin, albumin and factor VIII products.
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Plasma Protein Therapies not Suitable for Biosimilars
November 12, 2010
(November 12, 2010) -- The current science and experience does not support the safety and efficaciousness of a biosimilar pathway for plasma protein therapies. At a public hearing last week, the Plasma Protein Therapeutics Association (PPTA) urged the United States Food and Drug Administration (FDA) to make patient safety its top priority by adopting a global approach in its evaluation of plasma protein therapies for the biosimilars process.
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PPTA Launches German Language Educational Website on Donating Plasma
November 4, 2010
(November 4, 2010) – In an effort to provide information to potential plasma donors in Germany, a new German language website, DiePlasmaSpende.de has been launched. Produced by the Plasma Protein Therapeutics Association (PPTA), this new educational website features information on plasma donation, how it helps patients with chronic, life-threatening diseases, and will help users in Germany easily find their local source plasma donation center.
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PPTA Statement on Octapharma
October 27, 2010
PPTA has been informed by Octapharma of their decision to resign from PPTA as a Global and Regional Member. Octapharma has been a valued member of the Association since 2000 and we thank them for their many contributions during the last 10 years. We hope that Octapharma will decide to return as a Global Member in the future.
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PPTA Statement: HIV Transmission Reported by CDC
October 27, 2010
The U.S. Centers for Disease Control (CDC) reported recently that a kidney transplant patient in Colorado contracted HIV from a blood transfusion in 2008, the first U.S. patient to do so in eight years.
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PPTA Urges CMS for Appropriate Hospital Outpatient Reimbursement for Plasma Protein Therapies
September 7, 2010
ANNAPOLIS, MD (September 7, 2010)—The Plasma Protein Therapeutics Association (PPTA) recommends that the Centers for Medicare and Medicaid Services (CMS) finalize its Proposed Rule regarding reimbursement to better ensure patient access to vital medicines in the hospital outpatient setting.
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Dengue Virus and Plasma Protein Therapies
August 2, 2010
PPTA members are committed to providing safe and effective therapies. PPTA understands that people who rely on plasma protein therapies may have concerns about the possible transmission of Dengue virus through these therapies. PPTA considered available information on this virus and the available data clearly indicate that plasma protein therapies as manufactured by PPTA member companies provide high margins of safety against Dengue transmission.
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Plasma Protein Therapeutics Industry is Proud of its Commitment to Save Lives
July 29, 2010
“The documentary film Bad Blood: A Cautionary Tale, chronicles a tragic time in our country’s history that should never be forgotten and should never happen again. It depicts the struggle 25 years ago of government officials, physicians, scientists, patient organizations and others to identify an unknown virus, eventually known as HIV. In the midst of that struggle, people with hemophilia became infected.
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PPTA Nominates Two Industry Representatives for CER Board
July 16, 2010
The Plasma Protein Therapeutics Association (PPTA) has nominated industry experts Mary Gustafson and Dr. Albert Farrugia for consideration for the Board of Governors for the Patient-Centered Outcomes Research Institute (PCORI) to help guide the Board in its decisions regarding the treatment of individuals with rare diseases. PPTA is a global trade association that represents the manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies.
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PPTA Testifies at FDA Public Hearing on Rare Diseases
July 14, 2010
Providing information and context for the needs of patients suffering from rare diseases that require plasma protein therapies, the Plasma Protein Therapeutics Association (PPTA) presented at the recent U.S. Food and Drug Administration (FDA) public hearing, “Considerations Regarding Food and Drug Administration Review and Regulation of Articles for Treatment of Rare Diseases.”
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Statement on Review - Intravenous Alpha-1 Antitrypsin Augmentation Therapy
July 8, 2010
The article ‘Intravenous Alpha-1 Antitrypsin (AAT) augmentation therapy for treating patients with alpha-1 antitrypsin deficiency and lung disease’ by Drs. PC Gotzsche and HK Johansen claims that treatment of patients with AAT concentrate confers no benefit. This article is published by the Cochrane Collaboration as a ‘Review,’ which is generally taken to mean a comprehensive survey of a particular area of therapeutics. In this instance the ‘Review’ comprises analysis of just two clinical trials, both of them from the same group of investigators in Copenhagen, Denmark. In no sense can this ‘Review’ be considered as representative of the field of AAT augmentation therapy. It is questionable whether this ‘Review’ meets the criteria for publication in peer reviewed journals.
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Ruedi Waeger Wins Robert W. Reilly Award 2010
June 18, 2010
The Plasma Protein Therapeutics Association (PPTA) is pleased to announce it has elected Ruedi Waeger as the winner of the 2010 Robert W. Reilly Award. The award was handed out at the Plasma Protein Forum in Reston, Virginia on June 15.
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PPTA Statement: Xenotropic Murine Leukemia Virus-Related Virus (XMRV) and Plasma Protein Therapies
April 7, 2010
April 7, 2010 - PPTA members are committed to providing safe and effective therapies. PPTA understands that people who rely on plasma protein therapies may have concerns about the possible transmission of xenotropic murine leukemia virus-related virus (XMRV) through these therapies. XMRV was first isolated from human biological samples in 2006.1 It is a gamma-retrovirus that belongs to the viral family of Retroviridae, which are enveloped viruses.
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PPTA Statement on Signing of Health Care Reform Bill
March 30, 2010
March 30, 2010--“PPTA recognizes the historic achievement of President Obama and Congress in providing affordable, quality health care to millions of Americans. As the organization that represents the manufacturers of complex, biological therapies that treat extremely rare diseases and disorders, we have participated in the discussion surrounding health care reform for more than a year and have worked with Members of Congress to inform them of the unique nature of the industry and of the importance of preserving access for the fragile patient population our members serve.
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Plasma Collection Industry Meets with State Legislators about the Importance of Lifesaving Plasma Donations
March 25, 2010
SAINT PAUL, Minn.—March 25, 2010—Today, employees from the state’s 12 plasma collection centers are meeting with key state legislators to inform them of the importance of lifesaving plasma used to treat rare, chronic diseases and of the thriving business that plasma collection centers contribute to the state.
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Comment Period Now Open for Addition of Recovered Plasma Specification to QSEAL
February 16, 2010
In accordance with the procedures for developing a PPTA Voluntary Standard, the public comment period will be open for 60 days, until April 16, 2010.
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Kedrion Earns International Quality Certification For Manufacturing Lifesaving Plasma-Derived Therapies
February 5, 2010
ANNAPOLIS, MD (February 5, 2010) - The Plasma Protein Therapeutics Association (PPTA) announced today that Kedrion is the sixth company to be certified through its international Quality Standards of Excellence, Assurance, and Leadership (QSEAL) Program, which evaluates manufacturers of plasma protein therapies.
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PPTA Launches New Website Tool
September 23, 2009
ANNAPOLIS, MD (September 23, 2009) – Visitors to DonatingPlasma.org can more easily find their local plasma donation center now with an improved search feature. The Plasma Protein Therapeutics Association (PPTA), which developed the website to raise awareness of plasma donation, unveils the tool today, seeking to build on the importance of providing up-to-date information to donors who provide plasma needed to manufacture life-saving therapies.
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Plasma Protein Therapeutics Association Urges CMS for Appropriate Hospital Outpatient Reimbursement
August 11, 2009
ANNAPOLIS, MD—Aug. 11, 2009—The Plasma Protein Therapeutics Association (PPTA) supports the favorable recommendation of average sales price (ASP) + 6 percent for reimbursement of separately paid drugs and biologics in the hospital outpatient setting made by the Centers for Medicare and Medicaid Services’ (CMS) Advisory Panel on Ambulatory Payment Classification (APC) at its August 5-7 meeting, although third party data maintains that ASP +12 percent is the appropriate reimbursement level.
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Texans Help Produce as well as Benefit from Lifesaving Therapies
August 1, 2009
ANNAPOLIS, MD—August 1, 2009—This month, Texans are recognized for their outstanding contributions to lifesaving therapies that treat critically ill individuals and for their donations of the blood component, plasma, in one of 48 specialized plasma collection centers in the state that make the creation of the unique therapies possible. In June, the House of Representatives of the 81st Texas Legislature recognized August 2009 as “Plasma Protein Therapies Month” in the Lone Star State, helping raise awareness of the rare, genetic diseases treated with the therapies and valuing the contributions of voluntary plasma donors across the state.
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Plasma Protein Therapeutics Association Supports Patient-Centered Outcomes Research Act of 2009
July 21, 2009
ANNAPOLIS, MD—July 21, 2009—The Plasma Protein Therapeutics Association (PPTA) strongly supports S.1213, the Patient-Centered Outcomes Research Act of 2009, a bill that would establish a nonprofit corporation called the Patient-Centered Outcomes Research Institute to contract with appropriate Federal agencies or the private sector to conduct comparative effectiveness research (CER).
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New PPTA IQPP Cross Donation Management Standard
July 17, 2009
A new standard has been developed to screen donors prior to donation, to monitor their health periodically during their donation tenure and to limit the volume of plasma at each donation as well as the number of donations in a given period of time.
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Donor Check Form
July 17, 2009
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Audit Checklist
July 17, 2009
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FOLLOW-ON BIOLOGICS LEGISLATION MUST NOT PUT PATIENTS WITH RARE DISEASES AT RISK
June 16, 2009
ANNAPOLIS, MD—June 16, 2009—A white paper commissioned by the Plasma Protein Therapeutics Association (PPTA) to evaluate the effects of impending follow-on biologics legislation concludes that Congress should exempt plasma protein therapies unless safety and efficacy in a follow-on therapy can be clinically established.
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ABC’S “EXTREME MAKEOVER: HOME EDITION” HELPS FAMILY FACING RARE IMMUNE DEFICIENCY DISEASE TREATED WITH PLASMA-DERIVED THERAPY
May 10, 2009
Primary immunodeficiency diseases (PIDD) is a rare disease that affects the body’s ability to fight infection and that is treated with the biological therapy, immune globulin (Ig), that can only be made from donated plasma. Today, the Cerda Family of Las Vegas, Nevada, who have two children with a PIDD, will be the lucky recipients of a new home thanks to the ABC television show, “Extreme Makeover: Home Edition.” The new home will provide a better environment, free of mold, for the family.
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Plasma Protein Therapies in the Politico
April 29, 2009
In a big step to raise awareness for the need to protect patient access to plasma protein therapies, PPTA launched an 8-page advertorial in the Politico newspaper that also appears on www.politico.com/preservepatientaccess.
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Statement on the Safety of Plasma Protein Therapies and Swine Influenza Virus
April 28, 2009
PPTA member companies are committed to providing safe and effective therapies and PPTA understands that patients who rely on these often life-saving therapies may have concerns about the possible transmission of Swine Influenza Virus through them in view of the recent outbreak in humans. Therapies produced by PPTA members remain safe and available.
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Octapharma’s Wolfgang Marguerre Granted France’s Highest Military and Civilian Medal of Honor
April 24, 2009
Mr. Wolfgang Marguerre, the founder of Octapharma and a member of the Global Board of Directors of the Plasma Protein Therapeutics Association (PPTA), was granted “les insignes de Chevalier de la Légion d'Honneur,” France’s highest military and civilian Medal of Honor, by the French Minister of Health and Sports, Madame Roselyne Bachelot-Narquin.
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CIDP Treated with Plasma-derived Therapy
April 24, 2009
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a debilitating, progressive neurological disorder that results in muscle weakness and fatigue and can severely impair motor skills. According to the GBS/CIDP Foundation International, CIDP affects two to seven individuals per 100,000 worldwide. The rare disease is treated with intravenous immune globulin (IVIG), a plasma-derived therapy that replaces vital missing antibodies in a person’s plasma and that is manufactured by member companies of the Plasma Protein Therapeutics Association (PPTA).
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PPTA Backgrounder
March 23, 2009
Variant Creutzfeldt Jakob Disease (vCJD)
and the Safety of Plasma Protein
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Glossary of Terms
March 23, 2009
Transmissible Spongiform Encephalopathic (TSE) Disease
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PPTA Statement: February 19, 2009
February 19, 2009
PPTA Members Committed to Ensuring High Safety Standards for Plasma-Derived Therapies
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Cangene Corporation Joins PPTA's North America Division
January 12, 2009
Cangene Corporation, a Winnipeg, Canada-based leader in the development, manufacture, and commercialization of specialty hyperimmune plasma and biotechnology products, has joined the Plasma Protein Therapeutics Association (PPTA) North America division.
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Kawasaki Disease Treated with Plasma-derived Therapy
January 6, 2009
Patients with this Pediatric Disease Depend on Plasma Donation
Kawasaki disease is an uncommon illness that typically affects children between the ages of two and five and is a leading cause of acquired heart disease in children in the United States according to the American Heart Association (AHA). Kawasaki disease is treated with intravenous immune globulin (IVIG), a plasma-derived therapy that replaces vital missing antibodies in a person’s plasma and that is manufactured by member companies of the Plasma Protein Therapeutics Association (PPTA).
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Genetic Lung Disease Treated with Plasma-derived Therapy
December 23, 2008
ANNAPOLIS, MD—December 23, 2008—Alpha-1 antitrypsin deficiency is a genetic form of emphysema, a debilitating, chronic lung disease in which an individual is missing a vital protein produced by the liver. Patients with alpha-1 are treated with alpha-1 proteinase inhibitor (A1PI), a therapy that replaces that missing protein and that is manufactured by member companies of the Plasma Protein Therapeutics Association (PPTA). A1PI is produced from plasma donated by healthy, committed donors across the country. Plasma is the straw-colored, liquid portion of whole blood that remains when red blood cells, platelets and other cellular components are removed. Plasma is rich in proteins needed to clot blood, fight infection and ensure proper lung function.
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PPTA Press Statement: Erroneous Statements Threaten Patient Welfare and the Safety and Supply of Essential Medicines
December 15, 2008
The Plasma Protein Therapeutics Association (PPTA) condemns the attacks on the welfare of patients, the dignity of plasma donors and the authority of regulatory authorities expressed in the statement entitled “Self Sufficiency in Safe Blood in Europe,” by the Federation Internationalle Organisations de Donneurs de Sang (FIODS).
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PNS Test Event Mid-December
December 10, 2008
Be on the lookout for a test of the Patient Notification System, the free, confidential notice of plasma protein therapy withdrawls and recalls, in mid-December.
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PPTA Launches New Global Website
October 29, 2008
Today, the Plasma Protein Therapeutics Association launches its new website, which features information about the uniqueness of plasma protein therapies, the diseases and disorders they treat, and plasma donation.
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PPTA Launches New Educational Website on Donating Plasma
September 18, 2008
Today more people can learn about the life-saving benefits of plasma donation through the website, DonatingPlasma.org.
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PPTA Joins Stakeholders to Urge for Appropriate Hospital Outpatient Reimbursement
September 8, 2008
The Plasma Protein Therapeutics Association (PPTA) supports the recommendation of the Centers for Medicare and Medicaid Services’ (CMS) Advisory Panel on Ambulatory Payment Classification (APC) Groups to maintain the reimbursement rate of average sales price (ASP) +5 percent for drugs administered or dispensed in the hospital outpatient setting at its August 27-28, 2008 meeting.
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PPTA Names New Global Access Senior Director
August 11, 2008
The Plasma Protein Therapeutics Association (PPTA) has named Prof. Albert Farrugia as its new global access senior director. He will focus on improving global access to care worldwide for patients in need of life-saving plasma protein therapies.
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Advocates For Plasma Protein Therapies Meet With Legislators Today
May 14, 2008
WASHINGTON, DC--May 14, 2008-Today, another milestone is achieved in the plasma protein users community. National consumer organizations representing individuals with bleeding disorders such as hemophilia, alpha-1 antitrypsin deficiency, primary immune deficiency and advocates for plasma protein therapies joined industry to advocate together in furtherance of patient access to life sustaining plasma protein therapies.
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Patients With Rare, Life Threatening Diseases Meet With Minnesota State Legislators Today
April 23, 2008
ST. PAUL, MN-April 23, 2008-Today, individuals with primary immune deficiency diseases, hemophilia and alpha-1 antitrypsin deficiency will meet with state legislators to educate them on the need for a health care system that ensures them access to the life-saving therapies they need.
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Patients with Rare, Life-threatening Diseases Meet with Florida State Legislators Today
March 19, 2008
TALLAHASSEE, FL--March 19, 2008--Today, individuals with hemophilia and primary immune deficiency will meet with state legislators to educate them on the need for a health care system that ensures them access to the life-saving therapies they need.
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Paolo Marcucci Has Joined PPTA's Global Board of Directors
February 27, 2008
ANNAPOLIS, MD—February 25, 2008—Paolo Marcucci, President and CEO of Kedrion, a company specializing in the development, production and distribution of plasma-derived products, has joined the Global Board of Directors of the Plasma Protein Therapeutics Association (PPTA).
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Alabamans with Rare Diseases Declare Victory for Patient Care
December 12, 2007
ANNAPOLIS, MD--December 12, 2007--Patients enrolled in Alabama Medicaid, who rely on complex blood clotting factor therapies to control bleeding disorders such as hemophilia, achieved a recent victory that further secured their access to life-saving plasma-derived and recombinant analog therapies.
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PPTA Honors Outgoing Chairmen
November 21, 2007
In special ceremonies held recently in conjunction with PPTA Source’s Business Forum in Anaheim, California and PPTA’s Global Board of Directors meeting in Washington, D.C., the Association honored three exemplary individuals who have served as guiding forces in the plasma protein therapeutics industry.
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LAWRENCE P. GUIHEEN ELECTED PPTA GLOBAL BOARD CHAIRMAN
October 26, 2007
WASHINGTON, D.C.—October 26, 2007—Lawrence P. Guiheen of Baxter International Inc. today was appointed chairman of the Plasma Protein Therapeutics Association (PPTA) global board of directors, starting his new role on January 1, 2008.
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PPTA Names New Communications Manager
August 23, 2007
ANNAPOLIS, MD—August 7, 2007—The Plasma Protein Therapeutics Association (PPTA) has named Kym H. Kilbourne as its new communications manager.
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Dr. med. Wolfhart Kreuz Wins Hilfenhaus Award 2005
March 24, 2005
Award presentation at the International Plasma Protein Congress 2005 in Berlin, Germany on March 8, 2005.
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Industry Organization Calls Upon State Legislatures to Enact Medicaid Prior Authorization Exemptions for Life-Saving Plasma Therapies
July 20, 2004
Results of Texas Study Show that Prior Authorization is not appropriate for Anti-hemophiliac Blood Clotting Factor Therapies
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PPTA Updates Voluntary Industry Standards
July 2, 2004
PPTA Updates Voluntary Industry Standards. Changes include revision of previous requirements, addition of new standardsa and removal of obsolete standards (020677)
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Grifols Receives QSEAL Certification
July 30, 2003
The Plasma Protein Therapeutics Association (PPTA) announced that Instituto Grifols is the sixth company to be certified through its international Quality Standards of Excellence, Assurance, and Leadership (QSEAL) Program. PPTA President Jan M. Bult explained that “Grifols has successfully met the criteria of the voluntary program that was designed to demonstrate the leadership of this industry through the development of initiatives that enhance the continued safety and quality of lifesaving plasma therapeutics.”
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Industry Confirms Plasma Therapies Safe from West Nile Virus
October 7, 2002
Plasma-derived products do not represent a risk for the transmission of the West Nile Virus.
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QSEAL Recipients Recognized on Capitol Hill
November 7, 2001
On November 7, Congresswoman Hilda L. Solis of California hosted a presentation ceremony in her Capitol Hill office for members of the Plasma Protein Therapeutics Association (PPTA) who are the first to receive certification through the Association's QSEAL (Quality Standards of Excellence Assurance and Leadership) Program.
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