Regulatory Requirements for the Marketing of Cosmetics in the United States

2005 ◽  
pp. 862-889
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Requirements

scholarly journals The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union

2021 ◽  
Vol 25 (1) ◽  
pp. 32-40
Author(s):  
О.S. Popov ◽  
І.V. Kravchenko ◽  
V.Ye. Dоbrоvа ◽  
K.M. Tkachenko
Keyword(s):  
United States ◽  
European Union ◽  
Generic Drugs ◽  
Low Cost ◽  
The United States ◽  
The European Union ◽  
Regulatory Requirements ◽  
Drug Registration ◽  
Pharmaceutical Manufacturers ◽  
Mandatory Requirement

Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs. Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results. Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted. Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers. Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.

Microbial Contamination Occurring on Lamb Carcasses Processed in the United States

2001 ◽  
Vol 64 (4) ◽  
pp. 503-508 ◽  
Author(s):  
E. A. DUFFY ◽  
K. E. BELK ◽  
J. N. SOFOS ◽  
S. B. LeVALLEY ◽  
M. L. KAIN ◽  
...  
Keyword(s):  
United States ◽  
Microbial Contamination ◽  
The United States ◽  
Total Coliform ◽  
Regulatory Requirements ◽  
Salmonella Spp ◽  
E Coli ◽  
Total Incidence ◽  
Tissue Surface ◽  
Plate Counts

Lamb carcasses (n = 5,042) were sampled from six major lamb packing facilities in the United States over 3 days during each of two visits (fall or winter, October through February; spring, March through June) in order to develop a microbiological baseline for the incidence (presence or absence) of Salmonella spp. and for populations of Escherichia coli after 24 h of chilling following slaughter. Samples also were analyzed for aerobic plate counts (APC) and total coliform counts (TCC). Additionally, incidence (presence or absence) of Campylobacter jejuni/coli on lamb carcasses (n = 2,226) was determined during the slaughtering process and in the cooler. All samples were obtained by sponge-sampling the muscle-adipose tissue surface of the flank, breast, and leg of lamb carcasses (100 cm2 per site; 300 cm2 total). Incidence of Salmonella spp. in samples collected from chilled carcasses was 1.5% for both seasons combined, with 1.9% and 1.2% of fall or winter and spring samples being positive, respectively. Mean (log CFU/cm2) APC, TCC, and E. coli counts (ECC) on chilled lamb carcasses across both seasons were 4.42, 1.18, and 0.70, respectively. APC were lower (P < 0.05) in samples collected in the spring versus fall or winter, while TCC were higher in samples collected in the spring. There was no difference (P > 0.05) between ECC from samples collected in the spring versus winter. Only 7 out of 2,226 total samples (0.3%) tested positive for C. jejuni/coli, across all sampling sites. These results should be useful to the lamb industry and regulatory authorities as new regulatory requirements for meat inspection become effective.

scholarly journals Biosimilars: Are They Ready for Primetime in the United States?

2011 ◽  
Vol 9 (8) ◽  
pp. 934-943 ◽  
Author(s):  
Bradford R. Hirsch ◽  
Gary H. Lyman
Keyword(s):  
United States ◽  
The United States ◽  
Pharmacokinetic Parameters ◽  
The European Union ◽  
Approval Process ◽  
Regulatory Pathway ◽  
Regulatory Requirements ◽  
Economic Implications ◽  
Ensure Patient Safety ◽  
Critical Issues

The introduction of alternative versions of biologic products, also known as biosimilars, into the United States market has been gaining increasing visibility as patents for many agents are nearing expiration. Unlike generics, which are regulated under the Hatch-Waxman legislation passed in 1984, the approval process for biosimilars in the United States has not been defined. In 2004, the European Union established a regulatory pathway for these agents, and the FDA is now following suit. The economic implications are large, with $66.9 billion spent on the top 20 biologics in 2009. Of the top 10 biologics, 6 are routinely used in oncology. As the regulatory requirements are debated, several critical issues must be resolved. The most obvious is that the agents must be shown to be comparable to the original biologic they intend to replace. Knowledge of pharmacokinetic parameters alone will not be adequate, but the amount of clinical data required by the FDA remains unclear. The regulations will define the ease with which a biosimilar can be brought to market, and the associated costs of trials will influence the ultimate price of the medications. Balancing the needs of the relevant stakeholders is critical to ensure patient safety while controlling costs, improving access, and encouraging innovation. This is not an easy balance to strike.

Designing dementia treatment studies: Diagnosis, efficacy criteria, and duration

1996 ◽  
Vol 11 (3) ◽  
pp. 149-154 ◽  
Author(s):  
R Spiegel ◽  
P Irwin
Keyword(s):  
United States ◽  
Return On Investment ◽  
The United States ◽  
Regulatory Requirements ◽  
Regulatory Guidelines ◽  
Efficacy Criteria ◽  
Feasible Study ◽  
Long Term Studies ◽  
Symptomatic Benefit

SummaryDevelopment of treatments for dementia is beset by special problems in defining the diagnosis, establishing efficacy criteria, and specifying the necessary duration of study. There is need for agreement among clinicians and scientists on diagnostic subgroups of dementia. Similarly, there is a need for harmonization of the regulatory guidelines in Europe, Japan, and the United States regarding the decision set of variables on which to base efficacy claims. The duration of trials must be based upon the intended claim: transient symptomatic benefit, maintained symptomatic benefit, or a therapeutic effect on disease progression. Claims other than transient benefit require long-term trials, suggested to be of at least six months in duration. Problems with long-term studies include slow patient accrual, high dropout rates, changing milieu, low return on investment, and lack of unanimity regarding regulatory requirements. Regulatory authorities must come to some accord, consonant with current clinical/scientific wisdom and consensus, regarding diagnosis, efficacy criteria, and feasible study duration, in order to attract continued sponsor investment in the development of antidementia treatments.

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