Drugs

4 New CBER Standard Policies and Procedures

CBER issued four new Standard Operating Policy and Procedure (SOPP) documents on 2/27:

SOPP 8421: Complying with Requirements Under the Pediatric Research Equity Act (PREA) is a first-line resource for product offices and review divisions to ensure that sponsors/applicants and CBER staff are following the required procedures and timeframes under the act. The document applies to INDs, NDAs, BLAs, and related NDA and BLA supplements for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration. It is specific to PREA and does not discuss other pediatric regulatory issues.

SOPP 8422: Processing and Review of Trans-BLA Submissions covers for Center staff the administrative procedures for the receipt and review of trans-BLAs — multiple submissions to approved BLAs that contain an identical change or changes as a single submission. The document stresses that the change or changes must be identical and affect multiple approved marketing applications.

SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes covers proper names for biological products and drugs and the FDA-designated suffix applicable to each originator biological product, related biological product, and biosimilar product. The document describes the process for naming biological and drug products that are regulated by CBER.

Finally, SOPP 8413: Postmarketing Requirement/Commitment Related Submissions — Administrative Handling, Review, and CBER Reporting gives guidance for Center staff to administratively process, review submissions, and report on postmarketing requirements and postmarketing commitments received in CBER for BLAs and NDAs. The document applies to all postmarketing requirements and commitments for licensed biologics (including devices approved under a BLA) and drugs approved under an NDA that are regulated by CBER.

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