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The FDA hit Indian API manufacturer Alchymars ICM SM with a warning letter after an investigation found the firm falsified laboratory data, failed to thoroughly investigate complaints and improperly maintained equipment and facilities at its Chennai, Tamil Nadu facility. Read More
More states have aligned their oversight of drug compounding with federal standards in the last two years even though some states dropped inspections, according to an analysis by the Pew Charitable Trusts. Read More
Researchers at the FDA and the Centers for Medicare and Medicaid Services are considering whether a cell-based influenza vaccine might be more effective than the egg-based vaccine that did not prove very effective against this year’s H3N2 flu strain, according to Commissioner Scott Gottlieb. Read More
The Justice Department is creating a task force to combat the opioid crisis and plans to file a Statement of Interest in multidistrict litigation against distributors and manufacturers of opioids, according to Attorney General Jeff Sessions. Read More
The FDA issued A&Z Pharmaceutical a Form 483 for deficiencies at its Hauppauge, New York facility that included improper storage conditions, poor calibration practices and failure to review batch failures. Read More
The U.S. Department of Justice filed a complaint against Patient Care America, a Pompano Beach, Florida compounding pharmacy, claiming the firm made illegal payments to secure prescriptions for drugs reimbursed by TRICARE — the federally-funded health care program for military members and their families. Read More