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Regulatory & Safety: Top Headlines

Ocular Therapeutix has resubmitted Dextenza to US FDA after CRL

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23-Jan-2017 - Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.

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News in brief

EDQM outlines ICH Q3D impurities testing guideline integration plan

23-Jan-2017 - The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

GCP 'Renovation' paper outlines revisions to ICH E8 and E6

23-Jan-2017 - ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.

SUKL finds GDP problems at B.Braun warehouse in Czech Republic

19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of GDP guidelines.

GAO wants US FDA to show benefits of overseas inspections

18-Jan-2017 - The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.

US FDA criticises Sato Yakuhin Kogyo Co efforts to fix data issues

18-Jan-2017 - The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.

Janssen-Cilag switches Haldol supplies to Switzerland after production problems

17-Jan-2017 - Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.

Biosimilar interchangeability

FDA calls for switching studies in draft interchangeability guidelines

17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.

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