Analysis of ventilator fatal adverse events in FDA MAUDE database / 医疗卫生装备

The data on reported adverse events of ventilators in the U.S.Food and Drug Administration(FDA)Medical Device Manufacturer and User Facility Device Experience(MAUDE)database were searched from January 1,2022 to December 31,2022,of which the data on ventilator fatal adverse events were extracted and statistically analyzed with Python.The main causes for ventilator fatal adverse events were pointed out including degradation of noise-reducing foams,improper use and ventilator malfunction,and some suggestions were put forward accordingly from the aspects of material,manufacturer,user,maintainer and supervisor.References were provided for utilization management and adverse events control for other medical devices.[Chinese Medical Equipment Journal,2023,44(10):86-90]

A study of prescribing patterns in high-risk pregnancy at a tertiary care hospital

Background: High-risk pregnancy is defined as pregnancy complicated by factors that can adversely affect maternal and perinatal outcome. About 10–30% of pregnancies are high risk which accounts for 70–80% perinatal mortality and morbidity. Drug utilization data help to monitor the drugs prescribed and to assess the outcome by evaluating appropriateness and rationality of prescription. Aims and Objectives: This study aims to evaluate the pattern of drug use in high-risk pregnancy and to assess the WHO core prescribing indicator and US FDA category. Materials and Methods: A total of 250 case record forms of pregnant women admitted to high-risk ward were analyzed. Patient’s demographic data and detailed information about prescription were recorded and analyzed as per the WHO core drug prescribing indicators and US-FDA category. Descriptive statistics were used. Results: A total of 1121 drugs were prescribed among which antimicrobials (33.7%) were used more frequently followed by antihypertensive (13.9%), intravenous (609, 54.2%) route was the major route of drug administration, followed by oral (527, 47%), intramuscular (33, 2.9%), and subcutaneous (16, 1.4%). Average number of drugs per encounter was 4.48, percentage of encounters with an antimicrobials prescribed is around 70.4%, percentage of drugs prescribed by generic name was 93.5%, percentage of drugs prescribed from essential drugs list was 73.3%, and percentage of encounters with an injection prescribed was 50.4%. Majority of drugs belong to the US-FDA pregnancy Category B (45.04%), followed by Category C (39.4%), A (10.8%), and D (4.6%). Conclusion: Majority of drugs were prescribed by generic name and belonged to Category B drugs which are considered safe. Standards of prescription were in accordance with the WHO prescribing indicators. Overall prescribing behavior is rational and encouraging.

The Modern Engineering In Biosimiliar Drugs Development As Bioactive Gene Clonning

Bio therapeutic product tends to similar properties like- efficacy, Safety and qualityto a licensed bio- originator. USFDA guideline clearly said that Bio-Similar drugs are not genericmedications nor identical to the innovator medicine and also it’s not ensuring therapeuticequivalence with innovator drug. Getting Bio-Similar product marketing approval is achallenging task. To improve access of Bio-Similar drugs within the US market, US-FDA allowsabbreviated pathway for their approval. Recently India is becoming a most preferabledestination for Bio-Similar manufacturers, because of Make in India program. Introduction ofrecombinant technique to prepare Monoclonal antibody based Bio-Similar drug becomingpopular within pharmaceutical manufactures because of many recent patent expiries ofBiologics. The biologies are produced by cell culture method; hence, chances of variability’s aremore as comparable with the chemically synthesized conventional medicine and variousbiological medicines has led to developed Bio-Similar drugs across the globe. The biologies areproduced by cell culture method; hence, chances of variability’s are more as comparable withthe chemically synthesized conventional medicine. Therefor it is impossible to produce anidentical copy of an innovator product; hence, Bio-Similar is not considered as generic drugs.These drugs are Twin but not a clone of the innovator drug. The Bio-Similar drugs always facechallenges regarding verification of the similarity, the interchange ability, unique naming todifferentiate the various Bio-Pharmaceutical products, commercial opportunities, IPR andpublic safety.

A cross-sectional study of USFDA warning letters issued for cGMP violations pertaining to medical devices

Most of the prior studies concentrated on warning letters issued for clinical investigation, Institutional review board,and infringement of promotional claims, no studies assessed the warning letters issued for infringements of CurrentGood Manufacturing Practice (cGMP) pertaining to medical devices. Hence, there is a need to carry out a crosssectional study of these warning letters. Publically available U.S. Food & Drug Administration (USFDA) letters underthe law of the freedom of Information Act sent to the pharmaceutical company were accessed from the USFDA website.A standard data collection tool (Excel Spreadsheet) with all letters of warning issued from January 2008 to July 2018was developed. Letters have been manually screened. Warning letters related to medical device breaches of cGMPwere screened based on the letter's subject and content. Overall, 669 warning letters issued for medical device cGMPviolations were reviewed between January 2008 and November 2018. From 2008 to 2013, there was a downward trendin the issuance of warning letters. The number of warning letters issued in 2014 was 101, followed by 106 in 2015,as the USFDA focused more on data integrity issues, while the number decreased to 53, 27, and 19, respectively, in2016, 2017, and 2018. The highest number of warning letters were issued to manufacturers located in the USA (379),followed by Canada (52), and China (37). Section 820.30 of Title 21 CFR was found to be most violated with 603infringements. This section represents the design control requirements for cGMP. Class 2 type of medical devices werefound to be most violated (82%), followed by Class 3 with 7%. Only 32% of the companies responded to the warningletters although 52% Not Issued the closeout letter followed by 16% of the letters were considered as non-applicableletters. With the time, scientific developments and increased awareness of both regulatory authorities and industries/academic organizations, overall improvement are observed with significant decrease in the number of warning letters.

Review of new medical devices approvals by USFDA during the period of 2010 to 2014

Medical devices are health care products distinguished from drugs for regulatory purposes in most countries based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. Developing new medical devices requires clinical investigations and approval process goes through similar process like drugs. Medical device approvals in the period of 2010 to 2014 were searched from USFDA website. Diseaseburden data in the similar period was searched from centers for disease control and prevention website. Collected data was analyzed to know number of approved devices, top therapy areas, and mechanism of action of these devices. Out of a total of 200 medical devices approvals in the time period of 2010 to 2014,maximum number of devices (51; 25.5%) were approved in the year 2011, cardiovascular (78; 39%) was the top therapy area. Highest number (180; 90%) of approved medical devices belonged to the category III and maximum number (73; 36.5%) of approved medical devices had ?mechanical? mechanism of action. The top 3 causes of deaths in USA during 2010 to 2014 were heart disease, cancer and followed by respiratory infection. There was a match between the topdiseases and the medical device approvals for top 2 diseases in USA i.e. heart disease, and cancer. With respect to respiratory infections and ailments which was the 3rd leading cause of death only one device was approved out of 200 approvals in total.

Overviews and analysis of the U.S. FDA′s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016,the U.S. food and drug administration(FDA)approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals,this article introduces the description, mechanism of action and clinical studies;briefly describes the box warning,indications and usage,dosage and administration,dos?age form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and critical events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA’ s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016, the U.S. food and drug administration (FDA) approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug development and reaserch are emphasized.

A New Bioanalytical Method Development & Validation for Simultaneous Estimation of Esomeprazole and Naproxen in Human Plasma by Using RP-HPLC.

Aim: A new reverse phase high performance liquid chromatography (RP-HPLC) method for the quantitative determination of Esomeprazole and Naproxen in human plasma was developed and validated as per US-FDA guidelines. Methodology: The drug was spiked in the plasma and extracted with mobile phase by precipitation method. The extracted analyte was injected into Symmetry C18 (4.6 x 150mm, 5μm, Make: XTerra) or equivalent, maintained at ambient temperature and effluent was monitored at 285nm. The mobile phase was composed of potassium dihydrogen phosphate and acetonitrile [HPLC Grade] in the ratio of 60:40. The pH of the potassium buffer was adjusted to 3.0 by using Ortho Phosphoric Acid. The flow rate was maintained at 1.0 mL/min. Results: The developed method shows high specificity for Esomeprazole and Naproxen. The calibration curve for Esomeprazole and Naproxen was linear from 1.0 to 6.0 ppm (r2= 0.999) and 25.0 to 150.0 ppm (r2= 0.999) respectively. The inter-day and intra-day precision was found to be within limits. The proposed method was adequate sensitivity, reproducibility, and specificity for the determination of esomeprazole and naproxen in plasma. The Lower limit of quantification (LLOQ) for the drug Esomeprazole and Naproxen were found to be 0.04μg/ml and 0.4μg/ml respectively. The average percent recovery for the drugs Esomeprazole and Naproxen were found to be 98.97-99.84 & 99.80-100.95 respectively and reproducibility was found to be satisfactory. Conclusion: The proposed method was accurate, and precise for the quantification of Esomeprazole and Naproxen in the plasma. The proposed can also be used for routine analysis in quality control. The method was validated for parameters like selectivity, sensitivity, precision, intermediate precision, accuracy, linearity, recovery & stability. This RP -HPLC method is suitable for determining the concentration of Esomeprazole and Naproxen in plasma and it can applied for routine analysis for determination of the Esomeprazole and Naproxen from dosage form during pharmacokinetic study.