keyboard and monitors

Last week’s round-up, 28 October 2019 – 01 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


OGD Explains How it Reviews and Conducts Pre-ANDA Meetings

01 November 2019

The FDA’s Office of Generic Drugs (OGD) has explained how it evaluates and conducts meetings under its pre-abbreviated new drug application (ANDA) program.

To this end, the OGD has issued a manual of policies and procedures, which explains related practices. The manual includes the OGD’s criteria for granting or denying pre-ANDA meetings. It also details how to apply for such meetings, the timeframe for their review, and communication pre- and post-meeting:


Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

31 October 2019

The extent of surrogate endpoint use in European expedited approvals has been called “concerning” by researchers.

Research published last month showed that most marketing authorisations of products assessed via the EMA’s conditional marketing authorisation (CMA) and accelerated assessment (AA) pathways are based on pivotal trials that reported unvalidated surrogate endpoints. The study evaluated over 90 trials used to support related applications between January 2011 and December 2018. The researchers have stated that when such endpoints are used, clear post-authorisation measures should be required, within a reasonable timeframe, to confirm that clinical outcomes are achieved:


Industry Calls on FDA to Expand on Inactive Ingredient Database Guidance

30 October 2019

Stakeholders have called on the FDA to improve recently issued guidance on its Inactive Ingredient Database (IID).

The Association for Accessible Medicines (AAM) has asked the FDA to explain how to justify the use of an excipient when it differs from the IID listing in nomenclature, molecular weight, viscosity or grade. Pharmaceutical companies have asked for the guidance to be expanded to include biologics license applications. They’ve also asked for improved transparency, consistency and communication in relation to database updates:


Nitrosamine impurities overview

29 October 2019

The EMA has published templates that marketing authorisation holders should use following review of their medicines for the possible presence of nitrosamines.

The templates are divided into two groups; those that should be used to notify authorities about whether a risk of nitrosamine presence has been identified, and those that should be used following confirmatory testing on products identified to be at risk.

Marketing authorisation holders for centrally authorised products should send the completed templates to, whereas MAHs for nationally authorised products (including mutual recognition and decentralised procedures) should inform all national competent authorities where the respective product is authorized:

Full details and email addresses for notifications related to nationally authorised products are given on the CmDh website, a link to which has been provided here:


Pharmacopoeial Discussion Group achievements

28 October 2019

The latest Pharmacopoeial Discussion Group (PDG) meeting took place earlier this month between representatives from the European, Japanese and United States Pharmacopoeias.

Revisions to harmonised monographs on gelatin and sodium lauryl sulfate were signed off. The monograph for gelatin now covers all grades, and that for sodium lauryl sulfate includes a new identification method and revised assay method. The PDG also agreed a way forward for the future maintenance of ICH Q4B annexes, which deal with evaluation and recommendation of pharmacopoeial texts for use in ICH regions:


Image: Keyboard and Monitors, CC BY-NC 2.0

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