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FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure in mid-May, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers and ultimately moving to what may seem like stricter inspections, especially at first. Read More
The FDA sent a warning letter to Ranier’s Compounding Laboratory, based in Jeannette, Pa., noting serious deficiencies in sterile procedures and GMPs. Read More
A pharmacy chain operator that brought antitrust class action lawsuits against more than a dozen generics manufacturers earlier this week has added three more — Actavis Holdco, Lannett and Epic Pharma — claiming they colluded to raise the prices of the gallbladder stone treatment ursodiol. Read More
The Association of the British Pharmaceutical Industry will run advertisements later this month in three medical journals listing Astellas UK and Gedeon Richter as in breach of the ABPI’s Code of Practice, through the association’s Prescription Medicines Code of Practice Authority. Read More
The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers, clinical outcomes assessments and other methods to aid regulatory review. Read More
The FDA requested that Endo Pharmaceuticals voluntarily remove its opioid painkiller Opana ER from the market, saying its benefits may no longer outweigh its risks of abuse — the first time the agency has taken steps to remove a currently marketed opioid from sale. Read More