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Now that FDA is aligning its enforcement program with its product centers on May 15, there are questions about who in the agency should receive manufacturers' 15-day responses to Form-483 inspectional observations.
Latest From Manufacturing
Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.
FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.
US FDA official warns the pharmaceutical industry that investigators will continue to look for data integrity problems during inspections, and discusses “red flags” observed in inspections.
US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.
FDA's warning letter submitted following an October 2016 at Phillips Co.'s Millerton, Okla., facility states that the company does not appear committed to correcting the GMP, labeling and branding problems Office of Regulatory Affairs officials found.
FDA’s Pharmacy Compounding Advisory Committee votes to place coated modified release drugs on the “difficult-to-compound” list, thus barring these drugs from being compounded in the foreseeable future. The committee agreed with FDA’s recommendations that the complex formulation and the difficulty in manufacturing them precludes them from being compounded at the current time.
Expert shares cost-saving tips on compliance with US Drug Supply Chain Security Act's serialization mandate.
US pharmaceutical industry is warned that products “will not flow through the supply chain if the digital data is not right” under DSCSA, says official. Law’s second phase, which takes effect in November, mandates first-ever digital serialization requirements to ward off drug counterfeiting.
The growing complexity of procedures for making post-approval changes to product dossiers at global level is proving problematic for regulators and companies alike. Andrew Deavin, director of global regulatory affairs at GSK Vaccines, spoke to the Pink Sheet’s Ian Schofield about ongoing efforts to achieve greater regulatory convergence in life cycle management processes, including a new ICH guideline that could prove a “paradigm shift” in the handling of variations.
FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.
The European Commission has agreed to meet with a group representing the world's leading pharmaceutical inspectorates to discuss its concerns about the commission's proposal to relax GMP guidelines for cell and gene therapy products. Industry, hopeful that the commission is finally ready to listen, is looking to share its concerns again as well.
More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.
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