Drugs

CDER Commits to 11 Drug Quality Guides in 2025

A new CDER guidance agenda shows that the Center is committing to issuing 11 drug quality guidance documents in 2025. Under GMP pharmaceutical quality, the agenda says the following four documents will be published:

Approaches to Meeting CGMP Requirements for Distributed Manufacturing
Laboratory Testing of Drugs Held in Interstate Commerce: Compliance with CGMP
PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
Responding to Form FDA 483 Observations at the Conclusion of a Drug CGMP Inspection

Under chemistry, manufacturing and controls drug quality, the following seven documents are expected to be published:

ANDAs: Stability Testing of Drug Substances and Products Q & A
Container Closure Systems for Drugs, Including Biological Products
Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs
Guidelines for Establishing Impurity Limits for Antibiotics
Current Good Manufacturing Practice for Medical Gases; Revised Draft
Certification Process for Designated Medical Gases; Revised Draft

Additionally, regarding drug safety, CDER says it will publish a revised draft guidance on “Development of a Shared System or Separate REMS” and a final guidance entitled “REMS Logic Model: A Framework to Link Program Design with Assessment.”

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