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In a rare warning letter to an institutional review board, CDER’s Office of Scientific Investigations contends that an IRB at Monmouth Medical Center was lax in supervising research at the facility. Read More
Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety. Read More
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
Three stem cell treatment centers have been hit with an FDA warning letter critical of their recordkeeping and lack of required licenses for their clinical procedures. Read More
The FDA continues to turn up the heat on compounding pharmacies, issuing two warning letters to compounders in Kentucky and California for serious GMP deficiencies related to sterility. Read More
A December FDA warning letter to China’s Zhejiang Hisun Pharmaceutical outlines the company’s “systemic data manipulation” and cGMP deficiencies uncovered during a March 2015 inspection. Read More
The FDA has issued warning letters to two U.S. dietary supplement makers and a Hong Kong drugmaker — already under import alert in the U.S. — for significant cGMP violations over adulterated products and data integrity issues. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes. Read More
A federal judge has signed off on a Justice Department-backed consent decree for a permanent injunction against Texas compounder Downing Labs. Read More
The FDA said its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More