Drugs

FDA Drug Onshoring Policies Could Work: Attorneys

Reporting on the FDA 9/30 public meeting on onshoring manufacturing of drugs and biological products, attorneys Mark Schwartz and Julie Kim (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that if the agency can rapidly implement a PreCheck program that formalizes early, durable engagement; modernizes post-approval pathways; and alleviates lifecycle inspection bottleneck, “the pharmaceutical industry appears poised to translate expertise into faster, more resilient domestic manufacturing capacity.” Much of the meeting, they say, involved introducing the PreCheck initiative, which is intended to be FDA’s core mechanism for streamlining regulatory pathways for domestic manufacturing.

The initiative has two phases — facility readiness and application submission — and is built on three guiding principles: partnership, predictability, and preparedness, Schwartz and Kim write.

“While participants broadly accepted PreCheck,” they say, “they were candid about the most significant regulatory hurdles to establishing new U.S. active pharmaceutical ingredient facilities. Representatives from innovator, generic, biologic, and contract manufacturing organizations identified several key challenges that must be resolved to unlock domestic capacity.”

The post concludes with these recommendations that companies should consider in preparing to participate in PreCheck:

draft a facility drug master file architecture;
propose an engagement plan;
document prior knowledge; and
nominate a single point of contact.

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