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US FDA's GDUFA II commitment to alert generics firms within 90 days regarding inspection results will put additional pressure on Form 483 responses, possibly starting later this year.
Latest From Manufacturing
A position paper from the UK government has laid out some ideas for ensuring a smooth transition to a post-Brexit world in the area of regulation, with a focus on issues such as marketing authorization validity, continued regulatory oversight, inspections, and adverse drug reaction reporting.
The draft South African national intellectual property policy proposes a number of measures that will be of keen interest to R&D-based and generic industries alike. Part one of this article looked at patent matters including patentability criteria and opposition procedures. In part two, we examine proposals in areas like voluntary and compulsory licensing, parallel importation, and boosting local drug manufacturing capacity.
Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.
The EU Heads of Medicines Agencies has outlined some of the recent initiatives taken by the member states to deal with medicines shortages, including a new Dutch center and a member state coordinating initiative by the Irish regulator.
New EU guidance will help companies preparing marketing authorization applications understand what to include in Module 3 of their common technical document.
Ccompiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.
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