Drugs

Only 58% of Drug Postmarketing Requirements Filed on Time

The latest FDA report on the status of drug postmarketing requirements and commitments shows that industry is struggling to submit annual status reports on time, if submitted at all. As of 9/30/14 there were 639 open NDA/BLA postmarketing requirements, up from 613 on the same date a year earlier. Status reports must be submitted within 60 days of the anniversary date of U.S. approval of the original application or an alternate reporting date that was granted by the agency.

According to the report, there were 569 NDAs and BLAs with a status report due in FY 2014 (454 NDAs and 115 BLAs). Of the NDA status reports due, 58% (265/454) were received on time, 19% (88/454) were not received on time, and 22% (101/454) were not received during FY 2014, it says. Of the 115 BLA status reports due, 63% (73/115) were received on time, 19% (20/115) were not received on time, and 19% (22/115) were not received.

Earlier this year, the HHS Inspector General said that FDA was issuing more postmarketing study requirements to drug sponsors but continues to have problems with its data management system and work processes, which hinder its ability to track those requirements (see story). The report said that in 2006 the Inspector General found that the agency could not readily identify whether or how timely postmarketing studies were progressing toward completion, and that it lacked an effective monitoring system for the studies. Since then, it said, the FDA Amendments Act (FDAAA) has expanded the agency’s authority to require postmarketing studies and to take enforcement action when sponsors are out of compliance.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome