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FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

IPQ Monthly Update — April, 2013

The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come....

Debate Continues Among Stakeholders on Framework for Regulating Pharmacy Compounding; Legislative Options Reviewed at FDLI Forum

Congress, FDA, and the states, together with a wide mix of other stakeholders, are wrestling with how to define a more viable and coherent model for regulating pharmacy compounding – where the boundaries should be placed between state and federal oversight and what the respective regulatory structures and rules should look like....

QP Review of More Complex Supply Chains and Applications, EU Member State Differences, Among Issues Facing EMA in Annex 16 Revision

EMA’s GMP/GDP Inspectors Working Group (IWG) is wrestling with how to build into EU GMP Annex 16 the assurance that the Qualified Person (QP) understands the complexities of a globalized supply chain in certifying that a batch complies with GMP/GDP requirements and the new mandates of the Falsified Medicines Directive (FMD)....

EMA GMP Chapter Draft Revisions Focus on Current Compliance Focal Points from Shared Facilities to Defect Investigations

The European Medicines Agency (EMA) has released draft revisions of four of its GMP chapters, intended to communicate its expectations regarding current compliance focal points including supply chain oversight, shared facilities, starting materials, lab method transfers, and investigating and reporting quality defects....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

FDASIA’s Catch-All Title XI Includes Provisions on Medical Gases and Nanomaterials

A new system for the registration of medical gases and FDA participation in standard setting for nanotechnology particle-containing products are among the provisions in the catch-all Title XI of the Food and Drug Administration Safety and Innovation Act (FDASIA) that will further the Act’s impact on CMC and GMP regulatory processes....

FDA Field Alert Reports Required for Anomalies That Occur During Distribution

FDA expects firms to submit field alert reports (FARs) for recurring technical defects discovered through the complaint process even when there is no evidence of the issues in site production records or retained samples....

SFDA Completed Ten GMP Inspections of Overseas Manufacturers in 2011

In 2011, China’s State Food and Drug Administration (SFDA) completed ten GMP inspections of firms in the US, the EU, South Korea and India that manufacture vaccines, APIs, biologics, and oral solid dosage forms and sell their products in China. The overseas inspections were announced last October (IPQ “The News in Depth” Nov. 10, 2011), […]

FDA Publishes Interim Final Rule on Sole Source Reporting Requirements

In December, FDA published an interim final rule amending post-marketing reporting requirements for sole manufacturers of lifesaving drugs as part of its effort to address a recent surge in drug shortages.  The interim rule becomes effective on January 18. While existing regulations require that only permanent discontinuances be reported to FDA, in practice some manufacturers […]
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