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The News in Depth

J&J Tallies Up the Impact of its Compliance and Recall Problems in Quarterly Investor Update

During a July 20 J&J investor’s conference call covering the company’s second quarter results, Investor Relations VP Louise Mehrotra provided an update on J&J/McNeil’s current compliance situation and the significant financial and operational impact of the firm’s compliance and recall problems (IPQ “In the News” May 6, 2010)....

FDA Concern with McNeil’s Complaint Handling Extends to Lancaster, PA Facility

McNeil’s complaint handling – a problem area cited in FDA’s January warning letter to parent company J&J regarding their Las Piedras, Puerto Rico plant and in an April inspection at the OTC drug manufacturer’s Fort Washington facility (IPQ “In the News,” May 6, 2010) – was also of concern to agency investigators in an inspection completed July 9 at McNeil’s plant in Lancaster, PA.

Legislation Introduced to Provide FDA Mandatory Recall Authority for Human and Animal Drugs

Chairman Edolphus Towns (D-NY) announced that he has introduced H.R. 5740, “a bill to provide for the mandatory recall of adulterated or misbranded drugs,” that would amend the Federal Food, Drug and Cosmetic Act (FD&C Act), to provide new recall authority to FDA....

International Joint API Inspection Pilot Program Sees Positive Results

The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken....

Facility Listing Errors and Missing Development Data Draw Withhold Recommendations From FDA’s NJ District

Facility listing errors on the application and a lack of availability of development data source documents during pre-approval inspections are causing the New Jersey District to recommend withholding drug approvals, its investigations branch director Myriam Sosa told DIA’s June Annual Meeting....

Communication Between CMC and Clinical Groups is Key in IND Phase, FDA says

FDA Center for Drug Evaluation and Research (CDER) is stressing that communication problems between the CMC and clinical groups working in Phase I can result in important risks not being identified and can impede IND/Phase I progress....

Preparing for and Communicating Manufacturing Changes During Late Stage Development Smoothes Biotech Clearance Process with FDA

Comparability studies for changes which inevitably occur during Phases II and III for biotech products must be planned for by the firms conducting them, FDA is stressing. The agency is also cautioning that communication with FDA during the end-of-Phase-II and pre-Biologic License Application (BLA) meetings and through the submission and preapproval inspection important to understand common expectations and make it easier to work through issues that will arise due to these changes....

The New IPQ Publication “Monthly Update” is Now Available

Now available, the inaugural issue of IPQ’s “Monthly Update” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications has been expanded this Spring 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 uniquely valuable in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators....

ICH Q11 Guideline Structure and Content Taking Shape

The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline’s breadth and depth and its relationship to the other guidelines in the ICH quality family....

Regulatory Transparency vs. Industry Flexibility at Issue for Starting Materials in ICH Q11

The ICH Q11 Expert Working Group (EWG) has been wrestling with balancing regulatory transparency with industry flexibility in defining the starting material as it moves forward in drafting the guideline on drug substance development and manufacturing....
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