The FDA has published an updated Guidance Agenda – new and revised draft guidances CDER is planning to publish during calendar year 2012. Guidances of particular interest to nonclinical pharmaceutical toxicologists may include:
• Endocrine Disruption Potential of Drugs: Non Clinical Evaluation
• Integrated Summary of Safety
• Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications General Consideration
• Providing Regulatory Submissions in Electronic Format – General Considerations
• Providing Regulatory Submissions in Electronic Format – Study Data
• Providing Regulatory Submissions in Electronic Format – Standardized Study Data
Source: U.S. Food and Drug Administration
The authors – CM Wittich, CM Burkle, and WL Lanier – offer a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety. The article format addresses 10 common questions and their answers about off-label drug use. The breadth of application, its acceptance, and the liabilities of off-label use are explored. A history of FDA regulations surrounding the practice is presented, which helps to put its evolution into proper perspective. Off-label use, which occurs in every medical specialty, is more common in patient populations not likely to be included in clinical trials (e.g., pediatric, pregnant, or psychiatric patients). Once a medication is marketed, the FDA does not limit or control how the medication is prescribed by physicians. The pros and cons of the distribution of information regarding the off-label use of medications by pharmaceutical companies, the use of informed consent, and the liability of prescribing physicians are discussed.
Source: Mayo Clinic Proceedings – pdf of full article.
Linguamatics, the leader in natural language processing (NLP)-based text mining, announced that the Federal Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has licensed its 12E text mining platform as a discovery and decision support tool to supplement laboratory research efforts on drug safety. The FDA will use the platform to review published literature and drug product labels to address key biomedical issues, including mechanisms of drug toxicity and disease processes. In addition to document retrieval, the 12E platform can identify, extract, synthesize, and analyze relevant facts and relationships (e.g., between genes and diseases, drugs and side effects). Customers include top tier commercial, academic, and governmental organizations, including 9 of the top 10 global pharmaceutical companies. The 12E platform is available both as an in-house or cloud-based system.
Typical applications in pharmaceutical, biotechnology, and healthcare include:
• Mapping gene-disease relationships and identifying potentially novel therapeutic targets
• Biomarker discovery
• Drug repurposing
• Drug safety
• Patent analysis
• Clinical trial site selection and study design
• Mining electronic medical records to improve prediction of health outcomes
• Translational medicine
• Competitive intelligence
• Social media mining
• Subjective data mining (sentiment analysis, key opinion mining)
Sources: BioSpace and Business Weekly
An innovative Procedure Cage invented by Dr. Ryoichi Nagata, SNBL USA chairman, is at the center of a comprehensive program designed to significantly raise standards for non-human primate (NHP) care and thereby improve the quality of preclinical data collected.
The Procedure Cage attaches directly to an animal’s home cage allowing animals to enter on their own. This innovation significantly reduces animal stress by eliminating the need for capture-by-hand or use of other restraints, creating a calmer handling environment. In addition, the use of this separate cage for study-related procedures allows the animal to always view their home cage as a “safe place.”
The Procedure Cage is currently being tested at six beta test sites including key pharmaceutical industry, government, and university locations. The results will be presented at the American Association for Laboratory Animal Science (AALAS) National Meeting in Minneapolis on November 4-8, 2012. The Procedure Cage is available exclusively through SNBL USA.
Procedure Cage Demo: Click here
Source: SNBL USA newsletter (18 July 2012)
Analysis and overview of new drug reviews from 1993 through present by an over 20-year-active FDA veteran of drug approvals, Dr. John Jenkins (Director, Office of New Drugs, Center for Drug Evaluation and Research). The presentation includes review times and comparison to global approvals. Of note, median approval times for New Molecular Entities (NME) applications are 10 months, a 47% reduction from calendar year 1993. A status update on CDER compliance with past PDUFA goals is given, with information on forward planning to comply with PDUFA V goals. In accordance with the enhanced emphasis on benefit-risk analysis in PDUFA V, discussion of the anticipated framework and balance of stakeholder concerns is detailed. The PDUFA V program for NME review is presented, with key elements and projected timelines detailed.
This slide presentation gives excellent perspective of past and future trends for the global pharmaceutical market, with emphasis on FDA approvals of NME.
Source Slide Show (pdf hyperlink): FDA
What is new about PDUFA V? Congress, the media, and the public have a history of boiling down the issue to whether drugs are safe or not safe. In reality the issue is benefit versus risk. In addition, this judgement needs to be aligned with that of the patients who take the medication. Emphasis on this risk-benefit framework is a landmark difference in the pending PDUFA V legislation.
The increased requirement for combined chronic toxicity and fertility assessment of biologics has led to greater use of sexually mature non-human primates. Older animals have different needs compared to the younger, adolescent animals with which we are used to working. In addition, the establishment of sexual maturity requires additional parameter measurements, such as assessment of menstrual cycling, hormone analyses, and seminology. Changes in caging are required to reflect the social hierarchy inherent with the interaction of older primates, especially since subordinate animals mature later than their dominant peers. Provision of complex environmental stimuli also becomes a greater necessity. Due to the increased size and weight of older primates, handling becomes more of a potential source of stress and injury, to both animals and their handlers. Differential criteria for assessment of sexual maturity in primates are discussed.
Source: Developments in Life Sciences