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After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More
Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or efficacy. Read More
The FDA hit a La Habra, California compounding pharmacy with a warning letter for repeated violations, including dirty equipment and the presence of insects. Read More
Canadian sterile drug manufacturer Viatrexx was hit with an FDA warning letter for serious violations of aseptic practices observed during an agency inspection. Read More
Cosmaceutical Research Lab was hit with an FDA warning letter for serious violations uncovered during an inspection of the firm’s manufacturing facility in British Columbia, Canada. Read More
The FDA hit Tokyo-based drugmaker Takeda with a warning letter after an inspection revealed that manufacturing problems for its drug Natpara (parathyroid hormone) uncovered last year were still not resolved. Read More
The FDA has been forced to streamline its guidance development process during the COVID-19 pandemic, and the change is likely to shape its approach beyond the pandemic, says Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
The average inspection score for pharma manufacturing sites in fiscal 2019 dropped slightly from the year before, but scores for over-the-counter and homeopathic products significantly dragged down the global average, says a new FDA report. Read More
A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make purchases. Read More