Jeff Craven is a partner at the Regulatory Affairs Professionals Society (RAPS) and writes for various publications, including JD Supra and Medscape. His articles primarily focus on FDA regulations, medical devices, and pharmaceutical industry news, providing insights and analysis for regulatory professionals in the field.
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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
Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at the Orange County Regulatory Affairs Discussion Group annual conference.
By: Jeff Craven
Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during inspections of manufacturers, according to a US Food and Drug Administration (FDA) official who spoke at the Orange County Regulatory Affairs Discussion Group annual conference last week. @
By: Jeff Craven
Building a quality system for a cell and gene therapy (CGT) product requires a solid foundation based on knowledgeable staff, well-defined roles and decision-making, data integrity, independence of quality, effective procedures, and third-party oversight, according to a recent presentation at the Orange County Regulatory Affairs Discussion Group annual conference.
February 14, 2019 | Rheumatology News Other factors likely explain decreased rate of joint replacement FROM RHEUMATOLOGY
By: Jeff Craven
April 23, 2020 | Rheumatology News An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.
By: Jeff Craven
The more than 130 comments responding to the US Food and Drug Administration@s (FDA) draft guidance on clinical trial diversity were largely positive, with stakeholders wanting more information on the types of studies that require a Diversity Action Plan (DAP), alignment on data collection categories for demographics, applicability of DAP requirements to global trials, and what happens if sponsors fail to meet the outlined DAP requirements.
By: Jeff Craven
Of the 30% of new drugs approved between 2015 and 2021 with pediatric trial requirements under the Pediatric Research Equity Act (PREA), more than half had ongoing studies at a median of 5.6 years of follow-up, according to a recent research letter published in JAMA.
December 13, 2018 | Dermatology FROM JOURNAL OF PSORIASIS AND PSORIATIC ARTHRITIS
By: Jeff Craven
The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug Interactions (DIs) section for human prescription drug and biological product labeling as well as how drug interaction information should appear in other areas of the product@s labeling.
By: Jeff Craven
April 23, 2020 | Dermatology An international registry of adult and pediatric rheumatology patients is beginning to identify trends in the types of patients with COVID-19 and who is recovering.
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