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
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.
By: Jeff Craven
The US Food and Drug Administration (FDA) roadmap to reduce animal testing as a requirement for drug development has already made an impact after its first year, but the initiative faces future challenges in scaling and international harmonization, a group of experts wrote in a recent paper published in Stem Cell Research & Therapy.
By: Jeff Craven
India's National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological products as part of a recent revision to the country's drug pricing legislation.
