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What’s the best way to get ready for an FDA GMP inspection? Practice, says international quality expert Thomas Peither. Self-inspection or a fresh set of eyes in the form of an external consultant play an important role in audit preparation. Read More
The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping. Read More
FDA Commissioner Scott Gottlieb spent the early weeks of his tenure in the agency’s top job laying out his priorities before senior FDA staff and members of Congress and announcing the agency’s hiring freeze had officially been lifted. Read More
President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety and quality of drugs, which would cut federal spending by $854 million, to be replaced with $866 million in industry user fees. Read More
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
Janssen Biotech is suing Celltrion and Hospira in the latest of a series of lawsuits related to its blockbuster Remicade (infliximab) therapy. Read More
GlaxoSmithKline and ViiV Healthcare redeemed a priority review voucher for their application for a single-tablet antiretroviral regimen of Tivicay (dolutegravir) and Edurant (rilpivirine) for maintenance treatment of HIV-1 infections. The voucher allows for an expedited six-month review — cutting four months from the standard review. Read More