Drugs

Generally Positive Comments on PDUFA 7 Letter

The Alliance for Regenerative Medicine says it supports tools outlined in FDA’s PDUFA 7 commitment letter to share information and help improve communication between the agency and sponsors. In its comment letter, it raises a concern about the increasing reliance on written responses to requests to discuss important and often time-sensitive issues. The alliance says it urges FDA “to grant more face-to-face or teleconference meeting requests as they can actually be more efficient and informative for both CBER and a sponsor.”

The Personalized Medicine Coalition says there are many reasons why PDUFA 7 will make meaningful changes for the field of personalized medicine. The coalition focuses on agency staffing, real-world evidence and real-world data, and digital health and IT infrastructure.

Atara Biotherapeutics says it particularly appreciates FDA’s recommendations in the letter to enhance CBER’s capacity to support development, review, and approval of cell and gene therapy products, launch a pilot program to facilitate the expedited CMC development of products under INDs based on the anticipated clinical benefit of earlier patient access to products, and improve overall meeting management.

The American Society of Gene & Cell Therapy says it supports the commitment letter as drafted and is eager to assist FDA in PDUFA 7 reauthorization and the implementation of goals in the letter.

The comment letter from the Cancer Support Community says it appreciates procedures and goals in the letter to facilitate patients’ timely access to safe, effective, and innovative medicines. It urges the agency to expedite the publication of draft guidance by the end of 2022 that sets forth formal requirements on what patient experience data is collected in clinical trials and how it is uniformly captured, reported, and meaningfully and consistently communicated to ensure all stakeholders realize the full benefits offered by the programs.

Public Citizen suggests the commitments were drafted too much with the drug industry in mind and recommends the development of additional performance measures to assess the actual short- and long-term public health impacts of agency decisions on drugs and biologics. It also recommends that the letter include performance measures based on anonymous surveys of FDA reviewers and advisory committee members about their experiences reviewing NDAs and BLAs.

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