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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....

ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....

IPQ Monthly Update, June 2014

In focus are: ● FDA’s new process for risk-ranking ANDAs ● an update on other FDA efforts under GDUFA to clarify and streamline its generic drug review process ● the pressure coming from industry to establish an independent review process for new and modified excipients ● advice from FDA compliance experts on proactive GMP communications, and ● the compelling results of Amgen’s eight-year effort to upgrade its nonconformance investigations and follow-up processes to find and address root causes....

FDA Issues New BA/BE Draft Guidance

An FDA draft guidance for establishing bioavailability/bioequivalence (BA/BE) was released in late March and is intended to replace the existing 2003 BA/BE guidance. The guidance details the methods most suitable and accurate for the determination of BA/BE, as required by FDA. An expanded section is included on in vitro studies and their applicability for different formulations. […]

Interactions Between OGD’s Inactive Ingredients Database Working Group and IPEC on IID Content and Functionality Bearing Fruit

The cooperative effort between FDA’s Inactive Ingredients Database (IID) Working Group and the International Pharmaceutical Excipients Council (IPEC) to improve the IID’s content and functionality is beginning to bear fruit and will gain further momentum from the extra resources that will become available to the Office of Generic Drugs (OGD) to support projects that meet the Generic Drug User Fee Act (GDUFA) goals of creating a more efficient review process....

Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment

Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....

IPEC and a Broader Coalition of Industry Associations Identify ICH Q3D Implementation Challenges and What is Needed to Meet Them

The International Pharmaceutical Excipients Council (IPEC) and the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, of which IPEC is a member, have been taking a hard look at where the key challenges lie in implementing the elemental impurity standards in the new Step 2b draft of ICH Q3D and what tools they can provide to assist the pharmaceutical regulatory community in addressing them....

ICH Vets Another Pre-Step 2 Q3D Draft to Strengthen Consensus on Heavy Metal Standards

In mid-December, the ICH Q3D Expert Working Group (EWG) sent out a second, pre-Step 2 draft of its elemental impurities guideline to draw further input from constituent organizations on the challenging, broadly impactful issues it encompasses, with the target of achieving a draft that meets the Step 2 ICH consensus criteria by mid-2013....

Several Drug Substance Guideline Initiatives Moving Forward in Europe and ICH

Europe and ICH have several guideline initiatives underway that will help clarify and harmonize the regulatory expectations for drug substances and the control of their impurities....

FDA Releases Draft Guidance on Tablet Scoring

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