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HHS argues that the program would violate a criminal ban on any remuneration to induce purchase of any item “for which payment may be made in whole or in part under a federal health care program.” Read More
The Department of Health and Human Services (HHS) is pressing the Supreme Court to squash Pfizer’s appeal challenging the U.S. anti-kickback statute, filing a petition which lays out the department’s opposition to the patient assistance program Pfizer created to cover costs of its highest-priced drug. Read More
The agency observed that the facility’s environmental controls were inadequate to prevent cross-contamination of non-beta-lactam and beta-lactam drugs such as penicillin, raising the risk of allergic reactions in patients. Read More
The new recommendation extends the drug’s use to people with a forced vital capacity of more than 80 percent of expected normal lung capacity. Read More
Vanda Pharmaceuticals has vowed to appeal a federal judge’s dismissal of several patent infringement claims aimed at Teva Pharmaceuticals and Apotex over their generic forms of its sleep disorder drug Hetlioz (tasimelteon). Read More
The FDA has revised a guidance issued in July on failure to respond to a Complete Response Letter (CRL) from the agency for an abbreviated new drug application (ANDA), updating it to include commitments it made for reauthorization of the Generic Drug User Fee Amendments (GDUFA III). Read More
Centrient Pharmaceuticals’ active pharmaceutical ingredient (API) facility in Punjab, India, received a warning letter from the FDA for multiple deficiencies including lax records, test validations and inadequate contaminant controls. Read More