Background: Regulatory agencies operate their own advisory committee with external experts to address complex scientific issues in the approval of pharmaceutical products. However, each advisory committee operates very differently. Hence, the authors per-formed a comprehensive gap analysis among the committees operated by Food and Drug Administration (FDA), European Medicines Agency (EMA) and Ministry of Food and Drug Safety (MFDS). Methods: The regulations, guidelines, minutes and reports on advisory committees were retrieved from the websites of FDA, EMA and MFDS. A gap analysis comparing the advisory committeesof each regulatory authority was performed, including the disclosure of information and meeting procedures, and conflict-of-interest policies. Results: Substantial differences were found among the advisory committees in the strictness of conflict-of-interests and the transparency of meeting details. Whereas FDA and EMA disclose the detailed curriculum vitae of each committee member, MFDS does only names and majors. Whereas FDA live-streams each meeting and publishes the transcript of all dialogues by each member, EMA and MFDS release only anonymized summary minutes without live broadcasts. Whereas FDA and EMA require members to disclose their financial interests, MFDS merely requires signing a statement that confirms no conflict-of-interest. Conclusions Compared with Advisory Committee of FDA and Scientific Committee of EMA, the Central Pharmaceutical Affairs Advisory Committee (CPAAC) of MFDS appears to require substantial improvements in the disclosure of conflict-of-interests and the transparency ofmeeting details. This gap analysis will likely serve as a basis for policy discussions to improve the credibility of CPAAC.

Background: The authors performed gap analyses on the expedited programs associated with regenerative medicine therapies(RMTs), offered by Food and Drug Administration (FDA), European Medicines Agency (EMA) and Ministry of Food and Drug Safety (MFDS). ethods: The regulations and guidelines on expedited programs (e.g., Regenerative Medicine Advanced Therapy [RMAT] designation) associated with RMTs, and regulatory reviews on approved RMTs were retrieved from the websites of FDA, EMA and MFDS. Based on analyses of the retrieved materials, gap analyses were performed on the qualifying criteria, features and operational frameworks. Included were the comparisons of the expedited programs granted for tisagenlecleucel among the agencies. Results: FDA offers RMAT, Fast Track, Breakthrough Therapy, Priority Review designations, and Accelerated Approval. EMA’s programs include PRIority MEdicines (PRIME), Accelerated Assessment, Exceptional Circumstances, and Conditional Marketing Authorisation. MFDS implements a single Fast-Track Processing program. RMAT designation is specific to RMTs and can be utilized with FDA’s other expedited programs. PRIME applies to all medicinal products and can be used with EMA’s other programs.Fast-Track Processing program is specific to RMTs but combines all expedited features into a single track. Tisagenlecleucel received RMAT, Priority Review and Accelerated Approval for follicular lymphoma from FDA, PRIME for acute lymphocytic leukemia from EMA, and Fast-Track Processing for follicular lymphoma from MFDS. Conclusion FDA offers the RMAT designation exclusive to expediting the development, review and approval of RMTs in addition to other expedited programs, whereas EMA does RMT approvals under expedited drug approval programs. MFDS implements an exclusive, single-track program for RMTs.

Background: Rifampin exhibits highly variable exposure in tuberculosis patients, leading to adverse effects or treatment failure.This study aimed to develop therapeutic drug monitoring (TDM) strategy for rifampin using a single concentration-time point to estimate the area under the concentration-time curve (AUC), with the potential to reduce the number of blood draws. Methods: Plasma concentration(Cp)-time data were obtained from tuberculosis patients by collecting serial venous blood samples after rifampin administration. The Cp timepoint (Ct ) that predicts AUC best was explored using linear regression (Exploration). The accuracy and precision were evaluated using Bland-Altman plot. Physiologically based pharmacokinetic modeling approach was used to evaluate whether the single C t point identified in Exploration provides the best prediction of the AUC (Complement). Results: Cp-time data obtained from 26 participants were evaluable for the determination of AUC by Ct . In Exploration, C4 best predicted the AUC (r2 =0.91, p<0.0001), followed by C2 (r2 =0.84, p<0.0001). In AUC prediction by C4 , the datapoints for predict-ed and observed AUC pairs were randomly scattered in Bland-Altman plot with the mean bias of −0.029 μg · h/mL, and the 95% limit of agreement of −21.1 to 21.1 μg · h/mL. In Complement, C4,sim best predicted the AUC (r2 =0.86, p<0.0001), which supports that C4 reliably predicted AUC. Conclusions For improving treatment outcomes in the treatment of tuberculosis, a single concentration monitoring is applicable to rifampin TDM instead of AUC, potentially making the process less invasive, painful and cumbersome for patients, clinicians and healthcare providers.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The informa-tion on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale,application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion Each expedited program requiresa different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innova-tive medication development.

OBJECTIVE: This study was performed to compare the changes in the blood concentrations of tacrolimus when either itraconazole or voriconazole is together with tacrolimus to prevent or treat invasive aspergillus pneumonia (IAP) in patients with lung transplants. Therefore we can compare the degree of drug-drug interactions between tacrolimus and itraconazole against tacrolimus and voriconazole. METHODS: Patients who were admitted and had lung transplants in a territory referral hospital from September 2012 to May 2015 were analyzed retrospectively. The effects of itraconazole and voriconazole on the plasma concentrations of tacrolimus were analyzed. RESULTS: Mean tacrolimus concentrations was 10.49±2.35 ng/mL vs. 10.95±2.98 ng/mL (p=0.722), and mean concentration of tacrolimus over the dose of tacrolimus per day was 8.510±5.890 (ng/mL)/(mg/d) vs. 15.45±28.47 (ng/mL)/(mg/d) (p=0.947) in itraconazole vs. voriconazole group each. The ratio of the number of the results out of target tacrolimus concentrations to the total number of tacrolimus concentration results was 18.0±13.3% vs. 24.4±18.5% (p=0.185). CONCLUSION: There were no significant differences between itraconzaole and voriconazole to have influences on mean concentrations of tacrolimus over tacrolimus dose per weight per day. However voriconazole tended to raise tacrolimus plasma concentrations more than itraconazole. Safer and more effective drug management to prevent and treat fungal infections should be done by therapeutic drug monitoring not only of tacrolimus but of itraconazole and voriconazole in lung transplant patients.
Aspergillus ; Drug Interactions ; Drug Monitoring ; Humans ; Itraconazole* ; Lung* ; Plasma* ; Pneumonia ; Referral and Consultation ; Retrospective Studies ; Tacrolimus* ; Transplant Recipients* ; Voriconazole*

BACKGROUNDS: Patient counseling has been forced since June. 19, 2014. Prior to this, there was no study to try to standardize medication counseling to improve quality. PURPOSE: This study was to investigate satisfaction level and comprehension level between the pharmacist group and the patient group about standardized medication counseling sheet. METHODS: Questionnaires to assess standardized patient counseling sheet were posted at online survey software (Qualtrics) to pharmacists who worked at community pharmacy and patients who had visited community pharmacy before. RESULTS: Three hundred thirty five patients and three hundred nineteen pharmacists were responded to the questionnaire (Response rate: 72.9%). More than half of each group were satisfied with standardized medication counseling sheets 'for the general public', 'for the pregnant women and nursing mothers', 'for the chronic patient', and 'for the aged' and patient group were more satisfied than pharmacist group. Similarly, more than half of each group comprehended with the medication counseling sheets 'for the general public', 'for the pregnant women and nursing mothers', 'for the chronic patient', and 'for the aged'. Patient group tended to expect longer patient counseling time per one drug than pharmacist group. Also, the majority of both groups wanted to provide standardized medication counseling sheets constantly and extend for all drugs. CONCLUSION: Both groups were satisfied and comprehended standardized medication counseling sheets, and agreed to expand standardized medication counseling sheets to all drugs. So, it is necessary to build the standardized medication counseling of all drugs.
Comprehension* ; Counseling* ; Female ; Humans ; Nursing ; Pharmacies ; Pharmacists* ; Pregnant Women