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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
Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical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.
The Drug Controller General of India has reissued its demand for manufacturers to comply with a new self-inspection and reporting rule and has set a deadline for them to do so.
Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.
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