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Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy. Read More
The FDA said yesterday that Justice Department official Cynthia Schnedar will become director of CDER’s Office of Compliance starting Oct. 6. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA denied Teva its 180-day exclusivity period for a version of Warner Chilcott’s osteoporosis drug Actonel 150 mg because the agency itself didn’t tentatively approve Teva’s ANDA fast enough, according to an internal agency document. Read More
Canadian generics maker Apotex has lost a $520 million suit that the firm brought in front of an international arbitration board against the FDA over import alerts on two of its facilities. Read More
The FDA has warned four generic drug manufacturing facilities that they haven’t paid their GDUFA fees for the last two fiscal years, meaning all of their products are automatically misbranded. Read More
European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations for pharmaceuticals closer to those of the EU, although it may take another two years before the agreement is actually implemented. Read More
The FDA is explaining how generics firms can receive timely responses to their requests for information in a guidance that defines a new communications process known as “controlled correspondence. Read More
The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable. Read More
The Federal Trade Commission is suing AbbVie and its partner Besins Healthcare, along with generic firm Teva, over an alleged pay-for-delay deal that put off generic entry of AbbVie and Besins’s blockbuster testosterone gel AndroGel 1%. Read More
Australia’s pharmaceutical regulatory body has adopted European guidance on good pharmacovigilance practices for vaccines, including the reporting of reduced effectiveness or vaccine failure, and implementing a recall or halting distribution of batches. Read More