Newsroom

7-15/2010: PDA Announces Establishment of Missouri Valley Chapter

Fri, 23 Jul 2010 14:42:56 GMT

PDA Announces Establishment of New Chapter

7-12-2010: U.S. FDA Commissioner to give Keynote Presentation at 2010 PDA/FDA Joint Conference

Tue, 20 Jul 2010 16:33:38 GMT

U.S. FDA Commissioner to give Keynote Presentation at the 2010 PDA/FDA Joint Regulatory Conference

7-15-2010: PDA/FDA Joint Regulatory Conference Announces Key Industry and Government Speakers

Tue, 20 Jul 2010 16:20:24 GMT

2010 PDA/FDA Joint Regulatory Conference Announces Key Industry and Government Leaders as Speakers

Pharma Supply Chain Best Practices Identified at Manufacturer/Supplier/Regulator Workshop

Fri, 30 Apr 2010 16:31:29 GMT

Top supply chain experts representing pharmaceutical manufacturers, material suppliers, auditing companies, technology enablers, and the U.S. FDA participated in lengthy, brainstorming sessions. The Parenteral Drug Association and the U.S. FDA collaborated to develop a workshop that would facilitate various stakeholders clarifying the problems and identifying practical actions.

NASA Spaceflight Expert Confirmed Keynote Speaker for 2010 PDA Annual Meeting

Mon, 14 Dec 2009 16:54:04 GMT

The Parenteral Drug Association (PDA) has confirmed that Janice V. Meck, PhD, Director, Cardiovascular Laboratory, NASA-Johnson Space Center will present "Development of a Pharmaceutical Countermeasure for Post-spaceflight Orthostatic Intolerance" during the Opening Plenary Session of the 2010 PDA Annual Meeting.

EUROPEAN HEALTH AUTHORITIES TELL PHARMA COMPANIES TO REINFORCE SUPPLY CHAINS, PUT PATIENTS FIRST

Fri, 23 Oct 2009 14:38:29 GMT

Berlin (October 23, 2009) - The European Medicines Agency (EMEA) told industry manufacturing, control and regulatory professionals gathered at the 2009 PDA/EMEA Joint Conference that complicated supply chains, while necessary, are a weak link in quality control.

11-09-2009 Editor Bill Paulson to Become International Pharmaceutical Quality (IPQ) Publisher

Mon, 17 May 2010 09:09:50 GMT

In mid-November, PDA is turning over the publishing responsibilities for IPQ to Bill Paulson, who will continue to provide IPQ to PDA members on a complimentary basis for an interim period while subscription, site licensing and sponsorship opportunities are being pursued.

USP Unveils Second Draft of Key Environmental Monitoring Chapter at PDA Microbiology Conference

Wed, 07 Oct 2009 09:49:30 GMT

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USP Unveils Second Draft of Key Environmental Monitoring Chapter at PDA Microbiology Conference

Wed, 07 Oct 2009 09:38:33 GMT

2006 PDA Survey Helps Shape Standard

New Book on Environmental Monitoring Handbook Grows PDA's Library of Technical Information for Aseptic Processing Professionals

Fri, 02 Oct 2009 15:40:55 GMT

The Parenteral Drug Association (PDA) and DHI books have published volume three of Environmental Monitoring: A Comprehensive Handbook.

U.S. FDA Deputy Commissioner Outlines Principles in Keynote Address at PDA/FDA Meeting

Wed, 23 Sep 2009 14:21:22 GMT

U.S. FDA Deputy Commissioner Joshua Sharfstein, MD, previewed what direction the Agency's public health policies will take under new Commissioner Margaret Hamburg, MD, during his keynote address at the 2009 PDA/FDA Joint Regulatory Meeting in Washington, D.C. on September 14.

Richard M. Johnson Named PDA President

Wed, 26 Aug 2009 15:28:29 GMT

The Parenteral Drug Association, Inc. (PDA) has announced the appointment of Richard M. Johnson as the Association's next President, effective September 2009.

Perspective on Regulations from an Insider and a Patient to Close the 2009 PDA/FDA Joint Regulatory Conference

Thu, 24 Sep 2009 15:53:26 GMT

Something unique to the long-running PDA/FDA Joint Regulatory Conference will occur this year. Not only will the meeting delve deeply into the most pressing regulatory issues of the day, but its closing day will include a powerful reality check when regulatory affairs professional and breast cancer survivor Amy Giertych provides her unique perspective as both an insider and a patient.

FDA Principal Deputy Commissioner to Speak at the 2009 PDA/FDA Conference

Wed, 01 Jul 2009 13:43:05 GMT

Joshua M. Sharfstein, MD, principal deputy commissioner, U.S. FDA, has confirmed his role as a keynote speaker at the 2009 PDA/FDA Joint Regulatory Conference.

2009 PDA/EMEA Joint Conference Looks At Ensuring Patient Safety through Supply Chain Control and GMP

Thu, 24 Sep 2009 15:42:45 GMT

The PDA European office is pleased to announce that, so far, the 2009 PDA/EMEA Joint Conference features 15 confirmed speakers from pharmaceutical authorities across Europe.

PDA and PDA Taiwan Chapter Ink Deal for Closer Collaboration

Thu, 24 Sep 2009 15:36:15 GMT

The Parenteral Drug Association (PDA) reached a membership and information-sharing agreement with its chapter in Taiwan, which closely supports the Taiwan FDA (TFDA).

PDA Israel Chapter to host two PDA TRI courses in July

Thu, 24 Sep 2009 15:56:53 GMT

The Parenteral Drug Association Training and Research Institute (PDA TRI) and the PDA Israel Chapter are teaming up this July to bring the Institute's world-class training for the pharmaceutical/biopharmaceutical industry to Israel, with two courses covering regulatory hot topics.

2009 PDA/FDA Joint Regulatory Conference Keynote Speakers Look Ahead to 2020

Thu, 24 Sep 2009 15:48:32 GMT

The Parenteral Drug Association (PDA) has confirmed three keynote speakers for the 2009 PDA/FDA Joint Regulatory Conference who will discuss what the year 2020 will look like for the industry and what challenges must be overcome for the pharmaceutical industry, especially in the manufacturing segment of the industry.

PDA Comments on the U.S. FDA's Draft Guidance on Process Validation

Thu, 24 Sep 2009 15:31:54 GMT

The public comment period for the U.S. FDA's draft guidance on process validation generated more activity from PDA members since the Agency published its aseptic guidance for comment earlier in the decade. More than 400 comments were submitted to PDA, which established an online tool to collect the comments.

2008 PDA Press Releases

Wed, 15 Jul 2009 08:47:16 GMT

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U.S. FDA's Draft Guidance on Process Validation Elicits Response from PDA Members

Mon, 23 Mar 2009 08:20:41 GMT

Internationally Known Healthcare Author and Futurist Ian Morrison to Deliver Keynote Presentation at 2009 PDA Annual Meeting

Mon, 27 Oct 2008 07:38:46 GMT

The Parenteral Drug Association (PDA) has confirmed that Ian Morrison will speak during the Opening Plenary Session at the 2009 PDA Annual Meeting in Las Vegas, Nevada, April 20-24, 2009.

FDA's J. David Doleski and Nicole Trudel to Co-Present at 2009 PDA Annual Meeting

Fri, 07 Nov 2008 07:35:12 GMT

The Parenteral Drug Association (PDA) has confirmed that FDA's J. David Doleski and Nicole Trudel will co-present during the Opening Plenary Session at the 2009 PDA Annual Meeting in Las Vegas, Nevada, April 20-24, 2009.

2007 PDA Press Releases

Wed, 15 Jul 2009 08:48:31 GMT

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9/13/2007 PDA Revised Technical Report on Cold Shipping Takes Global View -- Training on the Document to occur in Germany in October, Ireland in November

Mon, 11 Aug 2008 17:11:22 GMT

Bethesda, Md. (September 12, 2007): The Parenteral Drug Association (PDA) has published Technical Report No. 39 (Revised 2007)...

06/18/2007 June PDA Letter Features Exclusive Interview with CDER

Mon, 11 Aug 2008 17:02:55 GMT

In this issue, CDER talks with PDA about the recent release of a U.S. FDA guidance titled Testing of Glycerin for Diethylene Glycol and an associated MedWatch Safety Alert.

06/07/2007: PDA Revises Flagship Technical Report on Steam Sterilization

Mon, 11 Aug 2008 17:00:01 GMT

Document to be Unveiled at Public Workshop in Chicago, June 26-27.

07/02/2007: PDA TRI has Moved!

Mon, 11 Aug 2008 16:59:55 GMT

On Monday, July 2, the PDA Training and Research Institute moved to a new location in downtown Bethesda, Maryland. The new facility features a state-of-the-art facility with an aseptic processing suite, two microbiology labs, a biotech lab, classrooms and student areas.

05/02/2007: May PDA Letter Celebrates TRI's 10th Anniversary

Mon, 11 Aug 2008 16:56:06 GMT

In this issue, we celebrate TRI's 10th Anniversary with articles from PDA staffers Gail Sherman, James Wamsley, Jessica Petree, Walter Morris and Lindsay Donofrio.

04/19/2007: Just Announced! Dr. Janet Woodcock Confirmed to Speak at PDA's QbD Workshop

Mon, 11 Aug 2008 16:55:39 GMT

Janet Woodcock, MD, Deputy Commissioner and Chief Medical Officer, FDA, has been confirmed to speak at PDA's Quality by Design for Biopharmaceuticals: Concepts and Implementation workshop in Bethesda, Maryland, May 21-22, 2007.

04/09/2007: April 2007 PDA Letter

Mon, 11 Aug 2008 16:52:53 GMT

In this issue, PDA's Robert Dana and Gail Sherman recount EMEA Inspection Sector Head Emer Cooke's discussion on the future of pharmaceutical manufacturing at the recent ISPE/PDA cosponsored Workshop on ICH Q8, Q9 and Q10.

03/18/2007: PDA Announces 2006 Member and Staff Honor Awards

Mon, 11 Aug 2008 16:51:36 GMT

PDA presented awards to several members and two staffers during the 2007 Annual Meeting in Las Vegas.

03/14/2007: PDA Technical Report No. 39 (2007 Revision) for review

Mon, 11 Aug 2008 16:50:15 GMT

PDA Technical Report No. 39 (2007 Revision), Guidance for Temperature Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment is now available for review and comment.

02/15/2007:USP/PDA Joint Conference on Residual Solvents - Presentation Files Available

Mon, 11 Aug 2008 16:46:13 GMT

USP and PDA co-sponsored an educational conference on Residual Solvents-Implementation of USP Requirements on January 18-19, 2007 in Bethesda, Maryland.

03/13/2007: March 2007 PDA Letter

Mon, 11 Aug 2008 16:43:30 GMT

In this issue, Jim Lyda, PDA, presents his perspective, "PIC/S: Why is It Important? What is Its Impact?," on what makes PIC/S important for a PDA member.

08/01/2007 July/August PDA Letter Highlights New Chapter in Technical Report No. 1 (Revised 2007)

Mon, 11 Aug 2008 17:07:29 GMT

PDA Managing Editor Walter Morris previews the new science contained in the recently published TR-1 (Revised 2007).

04/16/2007: Get Involved!

Mon, 11 Aug 2008 16:54:24 GMT

In honor of Volunteer Week, April 15-20, we encourage you to get active with PDA, boost your career and give back to the pharmaceutical and biopharmaceutical...

2006 PDA Press Releases

Wed, 15 Jul 2009 08:56:56 GMT

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12/19/2006: PDA Announces 2007 Board of Directors Election Results

Mon, 11 Aug 2008 16:36:55 GMT

Two newly elected Directors will join the PDA Board in 2007: Louise Johnson, Vertex Pharmaceuticals, and Martin Van Trieste, Amgen, Inc. Rebecca Devine, PhD...

11/09/2006: The Aseptic Processing Survey

Mon, 11 Aug 2008 16:33:11 GMT

This survey is intended to address aseptic processing practices for secondary manufacturing throughout th eworld. Feel free to make a copy of this...

10/12/2006: October 2006 PDA Letter

Mon, 11 Aug 2008 16:33:06 GMT

In this issue, PDA takes a critical look at the U.S. FDA Critical Path Initiative and considers what impact, if any, this program will have on the long-term health...

10/01/2006: Facilities and Engineering Interest Group Scope and Mission

Mon, 11 Aug 2008 16:16:36 GMT

The Facilities and Engineering Interest Group (FEIG) is a forum for discussing issues in the Pharmaceutical and Biotechnology industry of particular interest...

09/26/2006: PDA Call For Volunteers To Participate In Upcoming Technical Report

Mon, 11 Aug 2008 16:02:58 GMT

The PDA Technical Report #13 Task Force, chaired by Jeanne Moldenhauer...

09/05/2006: Special Award for Global Pharmaceutical Science Education

Mon, 11 Aug 2008 16:02:52 GMT

During this year's Graduate Student fellowship competition, the PDA received a series...

09/12/2006: PDA Filtration Interest Group Meeting

Mon, 11 Aug 2008 16:55:12 GMT

The PDA Filtration Interest Group met on September 12, 2006, in conjunction with the 2006 PDA/FDA Joint Regulatory Conference in Washington, D.C. Approximately twenty people attended.

PDA, HighWire Press Launch Project for Online PDA Journal

Fri, 20 Mar 2009 08:27:02 GMT

PDA and HighWire Press officially began a partnership to create a new, modern online experience for the readers of its 63-year-old PDA Journal of Pharmaceutical Science and Technology.

PDA's Library of Filtration Best Practices Grows Stronger with Revised TR-26 and TR-41

Fri, 27 Feb 2009 08:39:07 GMT

PDA members who work with sterilizing and viral filters will benefit from updated best practices included in the 2008 revisions of PDA Technical Report No. 26, Sterilizing Filtration of Liquids and Technical Report No. 41, Virus Filtration.

PDA Names Robert L. Dana Senior Vice President for Regulatory Affairs and PDA Training and Research Institute

Tue, 03 Feb 2009 11:00:32 GMT

In January 2009, Robert L. Dana, a long time PDA member, assumed new responsibilities within PDA. In his new role as Senior Vice President, Regulatory Affairs and Training and Research Institute, he will report to Bob Myers, President of PDA, and will also maintain a dotted line relationship to Rich Levy, PhD, Sr. VP, Scientific and Regulatory Affairs, PDA and will continue to serve as PDA's regulatory authority.