Press Releases
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PDA Quality Metrics Task Force to Comment on U.S. FDA Metrics Draft Guidance
Bethesda, Md., November 30, 2016 – The Parenteral Drug Association (PDA) is preparing comments on the U.S. FDA’s revised draft guidance for industry: Submission of Quality Metrics Data. The revised draft was issued after strong public interest and comment on the first draft, which was published in 2015. -
Parenteral Drug Association Celebrates 70 Years of Connecting People, Science and Regulation
Bethesda, Md., November 18, 2016 – The Parenteral Drug Association (PDA) marks its 70th Anniversary in November. PDA’s original Certificate of Incorporation was signed in November 1946 by its six original directors: Harold London, Rudolph Price, A. Lincoln Konwiser, Max Gold, Arthur Herrick, and Abraham Wagner. -
PDA’s PAC iAM Task Force Releases Work Plan to Reduce Manufacturing Change Barriers
Bethesda, Md., September 19, 2016 – The Parenteral Drug Association (PDA) has announced its program to reduce hurdles to pharmaceutical manufacturing innovation caused by disparate national regulations that discourage changes -
PDA Education to Offer FDA CDER Five Specialized Courses on Sterilization and Media Fills
Bethesda, Md., August 12, 2016 – The Parenteral Drug Association (PDA) Education—Where Excellence Begins—announces the development of five specialized courses for officials in the U.S. FDA’s Center for Drug Evaluation and Research, commencing in September and running through early 2017. -
PDA and PIC/S Offer 2-Day Training on GMPs for Pharma Ingredients in San Juan Aug. 8-9 Regulators from around the world will be on hand at the two-day event
Bethesda, Md., July 21, 2016 – The Parenteral Drug Association (PDA) invites pharmaceutical professionals and regulatory officials to participate in a 2-day, experienced-based training course on the application of good manufacturing practices (GMPs) regulations to active pharmaceutical ingredients (APIs) production in San Juan, Puerto Rico, August 8-9. -
U.S. FDA to Speak on Biosimilars at June PDA/PQRI Conference in Baltimore
Bethesda, Md., June 2, 2016 – The Parenteral Drug Association, Inc. (PDA) announced the participation of four confirmed officials from the U.S. FDA at its Biosimilars Conference, cosponsored with the Product Quality Research Institute, at the Hilton Baltimore, Baltimore, Md., June 20-21. -
PDA Trains Six Auditors from Two Companies in Quality Culture Assessment Tool Pilot
Bethesda, Md., May 19, 2016 – The Parenteral Drug Association (PDA) today launched a pilot for its Quality Culture Assessment Tool with an assessor training session. Members of PDA’s Quality Culture Maturity Task Force met with six auditors from two companies to introduce the assessment tool and learn how to apply it to simulated manufacturing case studies. -
Two PDA Leaders Recognized as Most Influential People in Drug Development and Manufacture in 2016
Bethesda, Md., May 10, 2016 – The Parenteral Drug Association, Inc. (PDA) is pleased to announce that its current volunteer Chair Martin Van Trieste (Amgen) and one of its past chairs, James Agalloco, have been recognized by The Medicine Maker among the “top 100 most influential people in the world of drug development and manufacture.” -
PDA Receives First Johnson & Johnson Kilmer Award for Contributions to Sterility Assurance Science
NEW BRUNSWICK, N.J. (May 6, 2016) – The Parenteral Drug Association, Inc. (PDA) was presented with the Kilmer Award in recognition of the Association’s longstanding leadership in contributing to the science of sterility assurance. -
PDA’s Leadership Challenges Next Generation of Parenteral Manufacturers to be Innovative
San Diego, Ca., April 19, 2016 – The Parenteral Drug Association, Inc. (PDA) opened its two-day workshop on current challenges in aseptic processing with a challenge to the younger attendees to question “why and why not” in regard to the way their companies manufacture sterile drug products. -
Parenteral Drug Association Publishes First-of-its-Kind Comparison of Sterile Processing GMPs
Bethesda, Md., February 9, 2016 – The Parenteral Drug Association, Inc. (PDA), the leading community for pharmaceutical professionals developing and manufacturing sterile drug products, today announced the publication of Global Sterile Manufacturing Regulatory Guidance Comparison – With link to Comparison Spreadsheet.