The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s top international officials said Friday. Source: Drug…
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, one of the agency’s top inspection officials…
The Clinical Trials Transformation Initiative is developing several new sets of recommendations relating to clinical trials — on the qualification of investigators, the potential legal and regulatory hurdles to decentralized…
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the…
An FDA advisory committee voted Thursday that Infocare’s NDA for stannsoporfin injection’s overall risk-benefit profile does not support the drug’s approval. Source: Drug Industry Daily
The administration is considering whether to revisit if drug companies’ rebates should be allowed safe harbor from anti-kickback laws in an effort to help curb rising healthcare costs, FDA Commissioner…
The FDA issued a Form 483 to AbbVie for its handling of complaints and samples. Source: Drug Industry Daily
Fresenius claimed it discovered “blatant fraud at the very top level of Akorn’s executive team [and] stunning evidence of blatant and pervasive data integrity violations,” after it had agreed to…
The FDA Antimicrobial Drugs Advisory Committee voted 15-0 that Achaogen’s NDA for plazomicin proved safety and effectiveness for complicated urinary tract infections in patients with limited or no treatment options.…
The FDA finalized guidance on assessing user fees under PDUFA VI — covering fiscal years 2018 through 2022 — describing the new fee structure and the types of fees organizations…