Drugs

2 CBER Standard Operating Policies, Procedures

CBER has issued two new Standard Operating Policies and Procedures (SOPP) to guide Center staff in dealing with resubmissions to an application or supplement and actions on biological product licenses.

SOPP 8405.1, Procedures for Resubmissions to an Application or Supplement, is a guide for the categorization and processing of a submission received in response to a complete response letter issued to an original application or supplement. It covers BLAs and NDAs and the associated efficacy, labeling, and manufacturing supplements subject to PDUFA, BsUFA, and resubmissions of applications for non-user fee products. It does not apply to BLAs subject to MDUFA or ANDAs subject to GDUFA.

SOPP 8403, Issuance, Reissuance, and Voluntary Revocation of Biological Product Licenses, describes (1) the process for issuing biologics licenses for new biological products and/or to applicants; (2) how changes to applicants or ownership of biological products will be administratively handled and reviewed; and (3) the process for the voluntary revocation of a U.S. license number, including a biological product under an existing license. It also describes the procedures and communications that should take place between CBER offices when processing and issuing these licenses.

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

Read more

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