PDA is conducting a survey of industry members challenged by the complexity of making post-approval changes.
The Parenteral Drug Association (PDA) has established a taskforce to explore opportunities to reduce the complexity of chemistry, manufacturing, and controls (CMC) regulatory post-approval change (PAC) processes and is conducting a survey to collect data on current (CMC) PAC processes. With current divergent requirements, PDA wrote in the letter on Dec. 15, 2016, the path to global approval of a post-approval change may increase the risk of drug shortages and incentivizes companies to keep things the way they are rather than facilitating modernization, maintaining a state of control, and achieving product realization-the objectives of International Council for Harmonization (ICH) Q10.
PDA is inviting individuals challenged by the complexity of making PACs to complete the survey. The association says it will release preliminary results at the 2017 PDA Annual Meeting from April 3–5, 2017 in Anaheim, CA. The survey will be available for completion until February 15, 2017. Anyone with questions is encouraged to contact Morgan Holland, of the PDA Science and Regulatory Affairs Department.
Source: PDA
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing
April 2nd 2025Sitting down with the PharmTech Group at INTERPHEX 2025, Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, discusses the design and critical role of walk-in chambers in the bio/pharmaceutical industry.