Content about Center for Drug Evaluation and Research

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

SILVER SPRING, Md. — The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

The FDA said it would rename the Office of Oncology Products the Office of Hematology and Oncology Products. The office, which is responsible for reviewing regulatory applications for pharmaceutical and biotech drugs for cancer, is overseen by the Center for Drug Evaluation and Research. Office of Oncology Products director Richard Pazdur will continue as director of the OHOP.

NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

SILVER SPRING, Md. — A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

NEW YORK — A ghost from 2008 soon could come back to haunt 2010.

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

BETHESDA, Md. The Food and Drug Administration could decide that some generic drugs are not equivalent to their branded counterparts, according to published reports.

WHAT IT MEANS AND WHY IT'S IMPORTANT Drug companies had better take a close look at their portfolios and make sure they aren’t marketing unapproved drugs. Any excuses they might have for making prescription drugs without regulatory approval will go unheeded by Food and Drug Administration officials.

(THE NEWS: FDA shuts down unapproved Glenmark, Konec drugs. For the full story, click here)