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Novel Excipient Enables Successful MannKind Inhaled Insulin Formulation; Formulation/Device Inhalation Technology Offers Platform Potential

The development, testing, and use of a novel excipient as part of its formulation enabled MannKind to develop a viable inhaled insulin product after other firms’ insulin inhalation projects had not been successful....

China to Implement Drug Distribution Reforms

China’s State Council stated in late February that it would implement drug distribution reforms. According to a Reuters report, this effort is designed to reduce substandard and counterfeit drugs through centralization and ensuring legitimate products reach rural areas.

2015 Planned Guidances

In late February, CDER published a list of new and revised draft guidances it plans to issue in 2015. Some of the topic areas of guidances to be issued are: ● biosimilars ● DSCSA implementation, and ● GDUFA completeness for APIs. Some specific guidances of interest are: ● CGMP data integrity Q&A ● environmental assessment […]

EMA Drug Identification Implementation

EMA announced the establishment of a task force for implementing international standards for the identification of medicinal products (IDMP) in early February. The task force creation follows from the finalization of ISO IDMP standards in 2012. Implementation guidelines are expected to be available in 2016.

European Medicines Verification Organisation Established

In mid-February, EFPIA, along with EGA and EAEPC, announced the establishment of the European Medicines Verification Organisation (EMVO). EMVO is designed to provide end-to-end verification of drugs from manufacture, through distribution to patients by creating an infrastructure for complying with EU’s Falsified Medicines Directive.

Comment Review, Public Meetings, Supply Chain Pilot to Follow 2014 Bolus of FDA DQSA Track & Trace Guidances

In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain....

Three FDA Guidances on Drug Supply Chain Security Act (DSCSA)

In late November and December, FDA issued three more guidances on implementing the provisions of DSCSA – the track and trace (Title II) component of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). Title I of DQSA addresses compounding. The three new DSCSA guidances cover:● the situations in which FDA will delay […]

Draft DQSA Track-and-Trace Q&A

In early October, FDA released a Q&A on provisions of Title II of the Drug Quality and Security Act (DQSA), which covers track-and-trace. The Q&A addresses how Title II will affect state standards, as well as when certain requirements come into effect. [For more on DQSA implementation see IPQ January 23 2014.]

Monthly Update, August-September 2014

In focus are: ● a significant proposal from prominent industry experts on revising the CMC submission paradigm to help spur transparency, QbD and continuous improvement, along with FDA reviewer comments on the proposal ● a series of new FDA guidances and an EU initiative on the generic drug review process ● Amgen’s MS-based “multi-attribute methodology” initiative to streamline biotech development and QC, and ● the Rx-360 keys to a strong supply oversight program and how Amgen is applying them....

Transparent Discussions, Long-term Relationships and Global Event Monitoring Mark Amgen’s Supply Oversight Program

Detailed, transparent technical discussions with suppliers, long-term supplier relationships, and a wide-ranging event monitoring system are three prongs in Amgen’s intensive effort to avoid supply disruptions and improve quality assurance....
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