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The Patient Advocacy Council, a Alabama-based commercial institutional review board (IRB), is disputing an FDA warning letter accusing it of failing to protect "economically and educationally disadvantaged subjects" in clinical trials it oversaw. Read More
Clark Research and Development failed to validate sterilization studies for its biocompatible hemoperfusion cartridges, according to an FDA warning letter. Read More
While a new vaccine has all but eradicated common causes of pneumonia, meningitis and ear infections in children, new strains of bacteria not covered by the vaccine have emerged, researchers are warning. Read More
The FDA approved Bell-More Laboratories to manufacture sterile pharmaceutical products after the company corrected several issues noted in an agency warning letter. Read More
Alcon Laboratories' retail sell sheet and sales aid for its antibiotic Ciprodex omit material facts, including important risk information and limitations, according to a warning letter from the FDA. Read More
A hearing implant company sponsoring a device study failed to provide clinical investigators with information on hearing loss among participants, and the sponsor of another device clinical trial provided "misleading" assurance to participants that the investigational device had been judged safe by the FDA, according to two separate FDA warning letters posted recently to the agency's website. Read More
Saying Seryx’s software is classified as a medical device, the FDA cited the firm in a recent warning letter for marketing its Signature Genetics program without first obtaining agency approval.
Austria-based Sanochemia Pharmazeutika violated quality system regulations (QSRs) by failing to maintain procedures to prevent contamination of its Fluorognost HIV assays, according to an FDA warning letter.
The FDA recently posted three separate warning letters to its website citing a sponsor, an investigator and an institutional review board (IRB) for a range of violations.
Bell-More Labs failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.