Drugs

OPQ MAPP to Speed Some NDA, BLA Approvals

FDA has issued a Manual of Policies and Procedures (MAPP) detailing how the CDER Office of Pharmaceutical Quality (OPQ) will facilitate and expedite the development, time to submission, assessment, and marketing approval of NDAs and BLAs for products that address unmet medical needs. The document helps fulfill agency commitments on chemistry, manufacturing, and controls (CMC) that are part of the PDUFA 7 commitment letter.

It has information on OPQ’s use of regulatory flexibilities to help overcome CMC readiness challenges. It applies to OPQ facilitation of CMC development in breakthrough therapy products, fast track products, and products included in the CMC readiness pilot described in the PDUFA 7 commitment letter.

FDA says the approaches described in the MAPP may also be considered for other products such as those that diagnose, treat, mitigate, cure, or prevent a serious disease or medical condition for which there is no other appropriate and available treatment; address drug shortages; or have an orphan drug designation.

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