United States (National)
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Jeff's coverage primarily revolves around health, healthcare, and pharmaceutical industries with a strong emphasis on FDA regulations and policy changes. Based on his articles, it is evident that he heavily relies on data and government announcements to support his coverage.
Potential pitches for Jeff may include commentary or analysis from experts within the healthcare or pharmaceutical industry in response to specific FDA warnings, regulatory updates, or new standards. Additionally, providing insights into how these changes could impact medical device companies or drug manufacturers would likely resonate well with him.
Considering Jeff's focus on legal policy regulations and citing data extensively in his work, sources who can provide detailed analysis of the implications of FDA actions backed by solid data are likely to capture his attention.
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By: Jeff Craven
COLUMBUS, OH – The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and provided an update on several ongoing initiatives at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.
By: Jeff Craven
COLUMBUS, OH – The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is which to properly handle problems that crop up in product software, two panelists recently told attendees, at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.
By: Jeff Craven
The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).
By: Jeff Craven
The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls (CMC) flexibilities for cell and gene therapy (CGT) products developed for biologics license applications (BLAs).
By: Jeff Craven
More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) representatives and industry members said at a public meeting hosted by Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy.
By: Jeff Craven
The US Food and Drug Administration (FDA) is more likely to approve drugs with an orphan designation that were indicated for subgroups of cancer or pediatric indications than the European Medicines Agency (EMA), the results of a recent cross-sectional study suggest.
By: Jeff Craven
During a public hearing on Thursday, the US Food and Drug Administration (FDA) received several suggestions from industry stakeholders on how to improve its Commissioner’s National Priority Voucher (CNPV) pilot program, though several observers were critical of the initiative.
By: Jeff Craven
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.
By: Jeff Craven
As cell and gene therapies (CGTs) continue to advance, they have unique developmental features that may require innovation in a clinical trial setting, the authors of a recent paper explained.
By: Jeff Craven
Among oncology drugs first approved by the US Food and Drug Administration, other regulatory authorities varied in how they approved the same products, both in terms of the regulatory frameworks and the evidentiary thresholds used as the basis for the approvals, according to recent research published in Frontiers in Pharmacology.
