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Final Guidances on Compounding Facilities

FDA issued two final guidances and one draft revision relating to compounding outsourcing facilities in late November. The final guidances address the Registration of Human Drug Compounding Outsourcing Facilities, including the process for registering, re-registering, and de-registering as an outsourcing facility, and the Fees for Human Drug Compounding Outsourcing Facilities, respectively. Also issued was a […]

Revised USP Chapters on Plastic Packaging

Issued in USP Pharmacopeial Forum 39(5) are new chapters and subchapters relating to the use of plastic packaging systems. New versions of chapter <661> and subchapters <661.1> and <661.2> discuss the selection of safe plastics with regard to extractables, leachables, and stability.

IPEC Seeks to Improve Excipient Maker/User Communications on Visible Particles

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is spearheading an effort to strengthen the communication pathway between excipient makers and users about the significance of benign visible particles in excipients....

CDER MAPP for Chemistry Review of QbR Submissions

A Manual of Policy and Procedures (MAPP) for Chemistry Review of Question-based Review (QbR) Submissions was released in mid-November. The MAPP clarifies how reviewers in OPS should assess NDAs and ANDAs that follow a QbR format. The document lists the benefits that come from using a QbR approach, and in the appendix, the 62 questions […]

Commissioner Hamburg in China

In a FDAVoice blog post about her trip to China in November, FDA commissioner Hamburg discussed the signing of an Implementing Arrangement with the CFDA to “create mechanisms for collaboration on inspections.” Also mentioned was the need for more agency staff in China – a concern of FDA’s in the wake of China’s delay in […]

FDA Criteria for “First Generic” ANDA

In the Federal Register in mid-November, FDA proposed a common definition for “first generic” in order to clarify the agency’s prioritization of ANDA approvals. A MAPP from August 2014 stated that the review of ANDAs that are “first to file” would receive prioritization, but did not provide a distinct definition. The Federal Register states that […]

FDA and EMA Meet on Mutual Reliance on GMP Inspections

In mid-November, EMA and FDA representatives met to clarify goals, scopes, and timelines for fostering mutual reliance on their GMP inspections. [For more on the FDA and EMA mutual reliance program see IPQ January 4, 2012.]

USP Compounding Compendium

USP released a new publication in mid-November designed to provide easy access to its quality-related standards for compounded medicines. The “USP Compounding Compendium” features more than 40 supporting general chapters and more than 170 compounding preparation monographs. The compendium will be updated with the release of new USP-NF editions and supplements.

FDA’s New Office of Program and Regulatory Operations Will Assume Pivotal Role in CMC Review

FDA’s Office of Program and Regulatory Operations (OPRO) – part of the new Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER) – will be responsible for co-leading and facilitating the review of the quality portions of new and abbreviated new drug applications (NDAs/ANDAs)....

CDER’s Office of Surveillance Will Oversee Expanding FDA’s QA Assessment Capabilities and Reshaping Inspections

The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility....
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