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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
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said June 1, adding that the current system of different expectations is not sustainable. Read More
Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay state Medicaid rebates when prices rise faster than inflation. Read More
A federal appeals court last month affirmed a lower court order preventing Actavis from replacing an older formulation of Namenda ahead of generic versions of the Alzheimer’s drug hitting the market in July. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More