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Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda

The ICH Q12 effort to create a more improvement-friendly and harmonized regulatory approach to pharmaceutical product lifecycle management is being driven by concern about the availability and reliability of supply as well as product quality and will address the “tough” regulatory issues involved, GSK CMC Regulatory Strategy VP Moheb Nasr stressed in an update on the ICH initiative in December. Nasr has been appointed to serve as Q12 rapporteur....

UK MHRA’s Compliance Management Upgrade Includes “Risk Intelligence IT System” for Drug Inspection Targeting

U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is creating a comprehensive “Risk Intelligence IT System” for determining where to deploy its inspection resources that captures and analyzes a wide variety of inputs from industry, public, and agency information sources....

Compounding Drivers and Problems Dissected by Merck Pharmacy Expert at April PDA Annual Meeting

Root causes of the problems in the pharmacy compounding arena range from the absence of training in pharmacy schools to commercial pressures that prompt established pharmaceutical firms to leave the market and force hospitals to rely on less qualified providers to fill their immediate patient needs, Merck Engineering BioSterile Validation Director Chris Smalley commented at the April PDA annual meeting held in San Antonio, Texas....

Brazil to Require Notice One Year Prior to Drug Withdrawal

A new mandate, approved by Brazil’s Anvisa in late March, requires drug manufacturers to provide a year’s notice prior to removing a drug from the market if that withdrawal could lead to a shortage. If the withdrawal would not pose a risk of a shortage, the notice can be given six months ahead rather than […]

FDA Reports Drug Shortage Decline to Congress

The first annual FDA report to Congress on drug shortages indicates a clear reduction in new shortages during the first three quarters of 2013. The reduction follows the granting of additional tools to FDA by FDASIA in 2012 and an executive order in mid-2013.  [See IPQ January 23, 2014 for more on CDER compliance initiatives.]

CDER Compliance Office Quality Regulatory Priorities for 2014 Include Implementing DQSA, FDASIA and Reorganization Plans

The top priorities at FDA’s Center for Drug Evaluation and Research (CDER) compliance office in 2014 will include implementing the compounding (Title I) and track and trace (Title II) provisions of the Drug Quality and Security Act (DQSA), signed into law in late 2013, along with the ongoing implementation efforts on the generic drug user fee (Title I), supply chain (Title VII) and drug shortage (Title X) facets of the 2012 FDA Safety and Innovation Act (FDASIA)....

Successful Tech Transfer to a CMO Depends on a Strong Quality Agreement and Open Communication Pathways, FDA Asserts

A detailed description of how a drug product owner will transfer technical knowledge to a contract manufacturer needs to be part of a quality agreement, FDA officials are stressing....

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....

IPQ Monthly Update — May, 2013

The IPQ "Monthly Update" for May is now available. Read this story for a concise summary of its contents.
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