Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule

The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes.     

Managing delegation in the FDA: reducing delay in new-drug review

This article examines the effects of the user fee reform on the speed of drug review in the U.S. Food and Drug Administration. The results show that even after controlling for increased agency resources, the reform reduced review times among new-drug approvals by 34 percent (95 percent confidence interval, 11 to 51 percent, p = .01). The results suggest that increased agency resources alone cannot explain the reductions in drug-review times. Evidence suggests that other reform-specific factors facilitated the change. Such factors may include the agency's desire to obtain program renewal and secure future fee revenues as well as heightened industry monitoring. Additional results show that there were significant increases in the speed of review for novel drugs in the reform era and for drugs in certain classes that have historically experienced longer delays. The results suggest that the user fee reform has helped politicians manage delegation and reduce delay in new-drug review.     

Back to first principles: a new model for the regulation of drug promotion

The US Food and Drug Administration''s (‘FDA’ or the ‘Agency’) current regulatory framework for drug promotion, by significantly restricting the ability of drug manufacturers to communicate important, accurate, up-to-date scientific information about their products that is truthful and non-misleading, runs afoul of the First Amendment and actually runs counter to the Agency''s public health mission. Our article proposes a New Model that represents an initial proposal for a modern, sustainable regulatory framework that comprehensively addresses drug promotion while protecting the public health, protecting manufacturers’ First Amendment rights, establishing clear and understandable rules, and maintaining the integrity of the FDA approval process. The New Model would create three categories of manufacturer communications—(1) Scientific Exchange and Other Exempt Communications, (2) Non-Core Communications, and (3) Core Communications—that would be regulated consistent with the First Amendment and according to the strength of the government''s interest in regulating the specific communications included within each category. The New Model should address the FDA''s concerns related to off-label speech while protecting drug manufacturers’ freedom to engage in truthful and non-misleading communications about their products.     

Identification of gunshot residue: a critical review

A review of the scientific papers published on inorganic gunshot residue (GSR) analysis permits to study how the particle analysis has shown its capability in detection and identification of gunshot residue. The scanning electron microscope can be the most powerful tool for forensic scientists to determine the proximity to a discharging firearm and/or the contact with a surface exposed to GSR. Particle analysis can identify individual gunshot residue particles through both morphological and elemental characteristics. When particles are detected on the collected sample, the analytical results can be interpreted following rules of a formal general interpretative system, to determine whether they come from the explosion of a primer or from other possible sources. The particles on the sample are compared with an abstract idea of "unique" GSR particle produced by the sole source of the explosion of a primer. "Uniqueness" is not the only problem related to GSR detection and identification for a forensic scientist. With "not-unique" particles interpretation of results is extremely important. The evidential strength of "not-unique" particles can increase with a more fruitful interpretative framework based on Bayes rule. For the assessment of the value of a GSR in linking a suspect and a crime, it is important to compare two hypothesis: the first can be that of the evidence if the suspect has been shooting in a specific situation, the second that of the evidence if the suspect was not involved in this shooting. This case specific or case-by-case approach is closer to what the court is interested in. The authors consider that a "case-by-case" approach should be followed whenever possible. Research of models and data such as those developed in other trace evidence material (fibres, glass, etc.) using a Bayesian approach is suggested in the interpretation of GSR.     

Sex offender management using the polygraph: a critical review

Reducing recidivism is a central goal in the treatment of sex offenders. In Europe, there is an increased interest in using the polygraph ("lie detector") as a tool in the treatment and risk assessment of convicted sex offenders. This interest originated from optimistic reports by American clinicians who argued that polygraph testing in the treatment of sex offenders is akin to urine analysis in the treatment of drug addiction. In this article, we critically examine the validity and utility of post-conviction sex offender polygraph testing. Our review shows that the available evidence for the claims about the clinical potential of polygraph tests is weak, if not absent. We conclude that portraying post-conviction polygraph testing as analogous to urine analysis is inaccurate, misleading, and ultimately, risky.     

Guardianship for crime prevention: a critical review of the literature

Cohen and Felson??s (Cohen and Felson American Sociological Review 44(4):588?C608, 1979) routine activity theory posits that for a crime to occur three necessary elements must converge in time and space: motivated offenders, suitable targets, and the absence of capable guardianship. Capable guardians can serve as a key actor in the crime event model; one who can disrupt, either directly or indirectly, the interaction between a motivated offender and a suitable target. This article critically reviews the literature on guardianship for crime prevention. Our specific focus is two-fold: (1) to review the way guardianship has been operationalized and measured, and (2) to review experimental and quasi-experimental evaluations and field tests of guardianship. Research on routine activities has had an uneven focus resulting in the neglect of the guardianship component (Reynald Crime Prevention and Community Safety 11(1):1?C20, 2009; Sampson et al. Security Journal 23(1):37?C51, 2010; Tewksbury and Mustaine Criminal Justice and Behavior 30(3):302?C327, 2003; Wilcox et al. Criminology 45(4):771?C803 2007). Evaluations of guardianship-related interventions demonstrate support for the theoretical construct; however, high-quality field tests of guardianship are wholly lacking. Implications for theory and research are discussed.     

Scheduling of new psychoactive substance the Swiss way: A review and critical analysis

Since the introduction of the European Early Warning System in 2005, >700 new psychoactive substances (NPS) have been listed. This review article presents for the first time the Swiss narcotic law in perspective of scheduling of NPS, and compares it to the regulations of the German speaking neighbours Austria and Germany.The Swiss way is a fast and effective way for scheduling NPS, with the purpose to restrict drug trafficking and for controlling the NPS drug market: the legal basis for scheduling substances of abuse is the “Law about narcotics and psychotropic substances” (BetmG, SR 812.121), which includes the “narcotic law directory (BetmVV-EDI, SR 812.121.11) suitable for listing all controlled substances. The BetmVV-EDI, SR 812.121.11 contains seven indices, with index e specifically designed for the fast scheduling of NPS. Newly appearing NPS can either be controlled under a structure analogues definition or by listing single substances. The list of single substances is updated at least once per year, and structure analogues definitions can be implemented, in order to keep track with new developments on the NPS market. The latest version from November 30th 2018 contains ten different structure analogue definitions and 207 single substances. Requirements to list NPS are their appearance on the NPS market, suspected psychotropic effects and their suggestions by Forensic professionals. As soon as substances are newly placed, on Schedule I of the 1961 Convention or Schedule II of the 1971 Convention by the Commission on Narcotic Drugs of the World Health Organization they can easily be transferred from index e to index a-d of the BetmVV-EDI, SR 812.121.11. The Austrian law uses a structure analogue and single substances approach (introduced in 2012, one update in 2016), whereas the German NPS law (established in 2016, no update yet) only lists two structure-analogue-definitions. All three legislations have defined which core structures, kinds and sites of substitutions are regulated.     

Treating sexual offenders with learning disabilities in the community: a critical review

This study offers a critical review of a treatment group for sexual offenders with learning disabilities. The participants were diverted from criminal proceedings due to their level of cognitive functioning and attended a 7-month treatment program comprising of four main components: sex education, cognitive distortions, offending cycle, and relapse prevention. A number of psychometric assessments were administered immediately before and after intervention. Although no significant differences were found in attitudes toward sexual offending following treatment, the trend was for improvements in sex knowledge and honesty of sexual interest. Improvements in socialization skills (leisure time and interpersonal skills) were significant. No further incidents of sexual offending have been reported during a 12-month follow-up. A number of explanations for the nonsignificant improvement in attitudes are considered and recommendations for future treatment evaluation studies are made. The development of specific questionnaires and treatment programs for sexual offenders with learning disabilities is discussed.     

A review of a framework for action: a four pillar approach to drug problems in Vancouver

A Framework for Action: A Four Pillar Approach to Drug Problems in Vancouver leaves the author of this review, Jan Skirrow, seriously conflicted. According to Skirrow, the Framework is a useful document and reflects well on those who prepared it, but skips over the hard issues by agreeing that drugs are the problem, and then moving on to repackaging the failed program approaches of the past. This, Skirrow says, is not the fault of those who participated in the planning exercise leading to the Framework. Rather, it results from a lack of courage on the part of society's policymakers.     

Experimental results of fingerprint comparison validity and reliability: A review and critical analysis

Our purpose in this article is to determine whether the results of the published experiments on the accuracy and reliability of fingerprint comparison can be generalized to fingerprint laboratory casework, and/or to document the error rate of the Analysis–Comparison–Evaluation (ACE) method. We review the existing 13 published experiments on fingerprint comparison accuracy and reliability. These studies comprise the entire corpus of experimental research published on the accuracy of fingerprint comparisons since criminal courts first admitted forensic fingerprint evidence about 120 years ago. We start with the two studies by Ulery, Hicklin, Buscaglia and Roberts (2011, 2012), because they are recent, large, designed specifically to provide estimates of the accuracy and reliability of fingerprint comparisons, and to respond to the criticisms cited in the National Academy of Sciences Report (2009).Following the two Ulery et al. studies, we review and evaluate the other eleven experiments, considering problems that are unique to each. We then evaluate the 13 experiments for the problems common to all or most of them, especially with respect to the generalizability of their results to laboratory casework.Overall, we conclude that the experimental designs employed deviated from casework procedures in critical ways that preclude generalization of the results to casework. The experiments asked examiner-subjects to carry out their comparisons using different responses from those employed in casework; the experiments presented the comparisons in formats that differed from casework; the experiments enlisted highly trained examiners as experimental subjects rather than subjects drawn randomly from among all fingerprint examiners; the experiments did not use fingerprint test items known to be comparable in type and especially in difficulty to those encountered in casework; and the experiments did not require examiners to use the ACE method, nor was that method defined, controlled, or tested in these experiments.Until there is significant progress in defining and measuring the difficulty of fingerprint test materials, and until the steps to be followed in the ACE method are defined and measurable, we conclude that new experiments patterned on these existing experiments cannot inform the fingerprint profession or the courts about casework accuracy and errors.     

Legal regulation of the drug khat in Australia

The plant Catha edulis, known more commonly as khat, has been consumed for centuries for its stimulatory effects, especially by people living in East Africa. As people from Somalia, Ethiopia and other East African countries have migrated to Australia, they have brought with them the practice of chewing khat. This article examines the claims made about the effects of khat on health and wellbeing and explores the approaches to the regulation of khat in Australia and overseas. The article concludes with a discussion of some of the concerns associated with current regulatory approaches and makes some suggestions for reform.     

The regulation of nursing in Australia: a comparative analysis

This article uses the International Council of Nurses framework for nursing regulation to examine Nurses Acts in Australian States and Territories. It measures their compliance with the standards contained in the framework and exposes the anomalies among jurisdictions in spite of mutual recognition legislation now in force in all jurisdictions, including the Commonwealth. It also provides examples of difficulties encountered with cross-border practice and concludes that there is an urgent need for national nursing legislation.