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Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports. Read More
Novartis has filed a complaint in federal court alleging Apotex infringed on its patent by seeking to manufacture, market and sell a generic version of cancer drug Zometa. Read More
The FDA is working on a new bioinformatic approach to evaluating the sameness of a generic drug’s active ingredient compared with that of the reference product. Read More
AbbVie filed a citizen petition June 3 urging the FDA to establish clear and transparent labeling requirements for biosimilars, saying this will avoid potentially unsafe substitution of the products and their reference products. Read More
The FDA has updated its guidance on refuse-to-receive criteria for ANDAs to include a reference to the Office of Pharmaceutical Quality, which didn’t exist when the guidance was finalized. Read More
The U.S. Supreme Court has declined to review a lower court ruling that upheld a California county ordinance requiring drugmakers to collect and dispose of unwanted drugs, in an outcome that could end up costing industry millions of dollars. Read More
A federal appeals court is considering whether to lift a temporary injunction that bars Sandoz from marketing it Zarxio-sndz biosimilar pending an outcome in patent infringement litigation involving reference product maker Amgen’s blockbuster chemotherapy drug Neupogen. Read More
The European Commission will revise four chapters of its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More