Included in the US coverage in IPQ’s just-released “Monthly Update — August 2010” is advice from FDA biotechnology regulators on how to communicate with the agency to avoid CMC stumbling blocks and smooth the development, IND and marketing application clearance process for new biotech products. On the inspection side, in focus are: ● Congressional efforts to upgrade FDA’s recall and supply chain authorities â—ŹÂ the latest on McNeil’s compliance issues and the impact on J&J finances â—Ź the new inspection initiative by CDER putting Part 11 back in the limelight, and ● a warning letter to Sanofi that shows FDA’s ongoing concern with vaccine manufacturing.
For Europe, key developments analyzed in the August issue include EMA’s increasing interactions with industry on biosimilars and an incisive analysis by retiring EMA Quality Head John Purves on the challenges confronting EMA over the next decade – from biosimilars, advanced therapies, personalized medicine and transgenics to variations and quality by design – and the need for more open scientific dialogue with industry to address them.
Internationally, a group of stories focuses on advancements in the ICH quality initiatives stemming from ICH’s June Meeting in Tallinn Estonia, including insights from Q11 rapporteur Brian Withers on how his expert working group is resolving the challenging issues around the guideline’s breadth and depth and its relationship to the other ICH guidelines. India’s rapidly expanding drug industry and the effort to create a stronger central regulatory authority to address it, along with some of the key GMP problem areas that have been identified in API manufacturing plants there, are also covered in the August issue. Another pair of stories focuses on the progress being made in developing international inspection programs, including requests for applicants for the FDA/EMA joint inspection program for finished products and a report from the EMA on the progress in the EU/US/Australian API pilot program. Also on the IPQ international radar screen for August is WHO’s effort to upgrade its GMP guidance.
The IPQ family of publications has been expanded to include breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.” These now accompany our in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators. All of our content is text-searchable at IPQPubs.com.
IPQ’s new offerings bolster our mission of helping readers understand, engage in and respond to the dialogue and developments around evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing. Subscribers and license holders to IPQ have access to all of these sources of cutting-edge news and in-depth analysis as well as to the full IPQ archives.
IPQ’s new “Monthly Update” publication covers the key GMP and CMC developments in the US, Europe, and internationally.
The August issue features important coverage of: ● a top FDA biotech regulator’s advice on how to successfully advance large molecule CMC during the product development, IND and NDA phases ● how FDA and Congress are seeking to strengthen the agency oversight of recalls and the supply chain ● the increase in biosimilar products, guidelines and requests for scientific advice in the EU ● important coverage of the latest advancements in the ICH quality initiative including Q11 following the ICH meeting and workshop in Tallinn, Estonia, and ● the growing traction the international joint inspection pilots are gaining and their future plans.
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