Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for the protection of public health by assuring that foods are safe, wholesome, sanitary and, properly labeled. Novel drug Approvals are usually innovative products to serve unmet medical needs or otherwise help to advance patient care. Methods: FDA novel drug approvals were analyzed from calendar year (CY) 2012 to 2018 based on not only their numbers but also BASED ON their impact, innovation, access, and predictability. Results: The total number of novel drugs approved from CY 2012 to 2018 was 279 (average 40 novel drugs/ year). Impact of novel drug approvals: 50% were first in class and 43% were for rare diseases. Overall expedited development and review methods were used in 63% of the novel drug approvals. Access of novel drug approvals: 84% were first-cycle approval, 74% were approved in the US before other countries, 58% priority reviews among novel drug approvals. Predictability of novel drug approvals: 98% approvals able to meet PDUFA goal dates for application review. Conclusions: Novel drug approvals during CY 2012-2018 had a high quality which is very much evident by their high impact, good access, and high predictability.

BACKGROUND Medical thoracoscopy, in the educated fingers of a pulmonologist, is a secure and powerful process for the diagnosis and treatment of many pleural diseases. If the centres for thoracoscopy are available, thoracoscopy should be carried out on those undiagnosed sufferers due to its excessive sensitivity in malignant and tuberculous pleural effusions. That is why the ultimate decade witnessed an interest in thoracoscopy as a diagnostic device for pleural diseases. In the existing study, we wanted to describe our experience with the function of thoracoscopic biopsy in patients who underwent thoracoscopy for diagnostic purposes. METHODS The study protocol and ethical approval were taken by the Institutional Review Board for human studies of B. J. Medical College, Gujarat. It was a prospective study conducted in the Department of Pulmonary Medicine, B. J. Medical College, Ahmedabad, between July 2014 and November 2016. 39 patients who underwent medical thoracoscopy for undiagnosed pleural effusions were enrolled in this study. Undiagnosed pleural effusion was defined as failure to achieve a diagnosis by initial pleural fluid analysis including pleural fluid adenosine deaminase (ADA) levels and at least three pleural fluid analyses negative for malignant cells. Diagnostic pleural fluid aspiration was done to obtain pleural fluid specimens. RESULTS In the present study with the help of thoracoscopy, 36 (92.31 %) patients were diagnosed successfully while only 3 patients remained undiagnosed. In the present study, on thoracoscopic examination 21 (53.85 %) patients had pleural nodules, 5 (12.82 %) patients had pleural thickening, 5 (12.82 %) patients had pleural plaquelike erythema. The remaining patients had other uncommon findings e.g. nonspecific pleuritis 3 (7.69 %). CONCLUSIONS Among all the patients with undiagnosed exudative pleural effusion, irrespective of smoking status which fails to respond to conventional medical management, diagnostic thoracoscopy should be considered as early as possible. The diagnostic yield of thoracoscopy for pleural pathology remains very high (92.3 %). KEYWORDS Diagnosis, Malignant Pleural Effusion, Thoracoscopy.

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Introduction: Diabetes mellitus is a leading public health problem all over the world. Diabetesmellitus is a risk factor that precipitating microvascular as well as macro-vascular pathologies.Several respiratory alterations have been reported in associations with Diabetes Mellitus. Therefore,the present study was designed to determine the effect of the disease on respiratory function inpatients with diabetes. Method & material: For this study 54 Diabetes Mellitus patients wereselected using simple random sampling from the diabetic clinic. 54 Non-diabetic, age & sex-matchedsubjects were also taken from teaching and non-teaching employees of the hospital for comparison.Result: In our study there was a statistically significant decrease in the level of FVC in DM patientscompared to healthy male subjects. There was a statistically significant increase in the level of ratioof FEV1/FVC. A more sensitive index of early disease is FEV1/ FVC ratio. Conclusion: Spirometricvalues were consistently lower in subjects with diabetes mellitus than in non-diabetics. Subjects withpoorer diabetic control have a worse spirometric function. We conclude that strict glycaemic control& regular breathing exercises to strengthen the respiratory muscles may improve the pulmonaryfunction test in patients.