InfaCare Pharmaceutical Announces Formation of New Product
Yahoo! News (press release) -
Debra Birenbaum, MD, board certified in Pediatrics and a Fellow of the American Academy of Pediatrics, brings broad regulatory experience to her role as Advisor to InfaCare. Prior to establishing an independent drug development and regulatory affairs consultancy in 2004, Dr. Birenbaum served at the Food and Drug Administration (FDA) since 1999 where she was the recipient of high- level awards for her achievement in promoting the public health of infants and children. While at FDA, Dr. Birenbaum led teams to help implement pediatric drug development legislative and regulatory initiatives. She was appointed Chairperson for the NIH-FDA Newborn Initiative, a collaborative effort between the two Agencies addressing the complex issues in drug development for neonatal and premature infant sub-populations. Dr. Birenbaum also chaired the FDA Pedicomm, a committee to help foster pediatric product development across multiple FDA Centers and represented FDA as an invited guest speaker at national and international meetings. A former Medical Officer in the Division of Pulmonary and Allergy Drug Products before assuming the role of Lead Medical Officer in the Division of Pediatric Drug Development, she conducted primary and consultative reviews of New Drug Applications (NDAs) and Investigational New Drug submissions (INDs), Proposed Pediatric Study Requests and Pediatric Written Requests for diverse pediatric pharmaceutical indications.
2006-06-20
InfaCare Pharmaceutical Announces Formation of New Product
Yahoo! News (press release) -
Debra Birenbaum, MD, board certified in Pediatrics and a Fellow of the American Academy of Pediatrics, brings broad regulatory experience to her role as Advisor to InfaCare. Prior to establishing an independent drug development and regulatory affairs consultancy in 2004, Dr. Birenbaum served at the Food and Drug Administration (FDA) since 1999 where she was the recipient of high- level awards for her achievement in promoting the public health of infants and children. While at FDA, Dr. Birenbaum led teams to help implement pediatric drug development legislative and regulatory initiatives. She was appointed Chairperson for the NIH-FDA Newborn Initiative, a collaborative effort between the two Agencies addressing the complex issues in drug development for neonatal and premature infant sub-populations. Dr. Birenbaum also chaired the FDA Pedicomm, a committee to help foster pediatric product development across multiple FDA Centers and represented FDA as an invited guest speaker at national and international meetings. A former Medical Officer in the Division of Pulmonary and Allergy Drug Products before assuming the role of Lead Medical Officer in the Division of Pediatric Drug Development, she conducted primary and consultative reviews of New Drug Applications (NDAs) and Investigational New Drug submissions (INDs), Proposed Pediatric Study Requests and Pediatric Written Requests for diverse pediatric pharmaceutical indications.
2006-06-19
The Nutritional Relationship Linking Sulfur to Nitrogen in Living
International News Service, Australia -
2006-06-18
InfaCare Pharmaceutical Announces Formation of New Product
Yahoo! News (press release) -
Debra Birenbaum, MD, board certified in Pediatrics and a Fellow of the American Academy of Pediatrics, brings broad regulatory experience to her role as Advisor to InfaCare. Prior to establishing an independent drug development and regulatory affairs consultancy in 2004, Dr. Birenbaum served at the Food and Drug Administration (FDA) since 1999 where she was the recipient of high- level awards for her achievement in promoting the public health of infants and children. While at FDA, Dr. Birenbaum led teams to help implement pediatric drug development legislative and regulatory initiatives. She was appointed Chairperson for the NIH-FDA Newborn Initiative, a collaborative effort between the two Agencies addressing the complex issues in drug development for neonatal and premature infant sub-populations. Dr. Birenbaum also chaired the FDA Pedicomm, a committee to help foster pediatric product development across multiple FDA Centers and represented FDA as an invited guest speaker at national and international meetings. A former Medical Officer in the Division of Pulmonary and Allergy Drug Products before assuming the role of Lead Medical Officer in the Division of Pediatric Drug Development, she conducted primary and consultative reviews of New Drug Applications (NDAs) and Investigational New Drug submissions (INDs), Proposed Pediatric Study Requests and Pediatric Written Requests for diverse pediatric pharmaceutical indications.
2006-06-16
The Nutritional Relationship Linking Sulfur to Nitrogen in Living
International News Service, Australia -
2006-06-15
An Update On Prenatal Diagnosis And Treatment Of Congenital
Medical News Today (press release), UK -
The next abstract by Dr. Oguejiofor from Oklahoma discussed their experience with the prenatal diagnosis and management of congenital mesoblastic nephroma and neuroblastomas in neonates. They found that MRI is helpful with no added morbidity to the patient or mother. Dr. Baker presented Juvenile Granulosa Cell Tumor in a 45, XO/46, XY intersex child. There have been only six cases in the literature to date with ambiguous genitalia. The tumor in their patient was an intermediate stromal tumor. Dr. Gomez from Miami, Florida, USA discussed neonatal testicular tumor, also a granulosa cell tumor. They are benign in neonates and aggressive in older children. Dr. Prieto discussed Multicystic Dysplastic Kidney (MCDK) and a case involving a segmentally affected horseshoe kidney. Their review showed that for all MCDK, 35% had a UPJO, 10% were duplex, 50% had VUR, and 4% hypospadias. The overall incidence of MCDK is 1:4300. Approximately 30% of patients with a horseshoe kidney have some other form of congential abnormality such as heart, limb, or lung. The next abstract by Dr. Leslie from Indiana University discussed the puncturing of a prolapsing ureterocele that was causing bladder outlet obstruction in utero with an acute oligohydramnios and contralateral perinephric urinoma. Dr. Elmore from Emory University in Atlanta, Georgia showed a laparoscopic approach to Familial Transverse Testicular Ectopia and their case had an associated persistent Mullerian Duct Syndrome. They also discussed that 98% of these patients have an inguinal hernia and 30% have a persistent Mullerian Duct Syndrome. The next abstract dealt with the use of MRU in the diagnosis of UPJO in ectopic kidneys. There is an overall 37% of UPJO in ectopic kidneys. They utilized contrast perfusion values that correlate to GFR and degrees of obstruction and function. The last presentation of the day was by Dr. Chang from the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA on a 7 year old child presenting with ambiguous genitalia. This child had a femal circumcision performed. They discussed four types of female circumcision. Type I - Sunna (partial or complete clitorectomy); type II - type I with removal of the labia minora; type III - infibulation that constitutes type II with removal of the labia majora as well along with reapproximation causing a small introitus; type IV - piercing, burning, or stabbing of the genitalia to cause scarring and a change in external appearance. It is not driven by religion and seems more cultural.
2006-06-14
Baxa Launches New 35 mL Exacta-Med� Oral Dispenser
dBusinessNews Denver (press release), CO -
Baxa, a customer-focused medical device company, provides innovative, solution-based technologies for fluid handling and delivery. Its systems and devices promote the safe and efficient preparation, handling, packaging, and administration of fluid medications. Key products include Rapid-Fill� Automated Syringe Fillers, Exacta-Med� Oral Dispensers, MicroFuse� Syringe Infusers, Repeater� Pharmacy Pumps, and Exacta-Mix� and MicroMacro� Multi-Source Compounders; used worldwide in hospitals and healthcare facilities. Privately held, Baxa Corporation has subsidiaries and sales offices in Canada and the United Kingdom; sales infrastructure in Belgium, Denmark, Finland, France, Germany, Luxembourg and the Netherlands; and distribution partners worldwide. Further information is available at
1. Parenteral Nutrition-Associated Cholestasis in Neonates: Multivariate Analysis of the Potential Protective Effect of Taurine/Discussant/Author''s Response
ABSTRACT. Background: Neonates receiving parenteral nutrition (PN) are at risk for PN-associated cholestasis (PNAC); however, no preventive factors for ...
2. Follow-up study of adolescents exposed to Di Phthalate as neonates on extracorporeal membrane oxygenation support
Di(2-ethylhexyl) phthalate (DEHP) is used to make polyvinyl chloride (PVC) plastic tubing soft and flexible. Animal data show that adverse effects of ...
3. High-Frequency Ventilation in Premature Neonates
To the Editor: With great interest we read the review paper by Bollen and colleagues (1), which was submitted for publication before our paper "Development ...
4. Cumulative Metaanalysis of High-frequency Versus Conventional Ventilation in Premature Neonates
Mechanical ventilation can induce lung injury, particularly in premature and diseased lungs. There is increasing evidence that high peak inspiratory pressures ...
5. Body Composition of Neonates From Fan Beam Dual Energy X-ray Absorptiometry Measurement
ABSTRACT. Background: Fan beam dual energy x-ray absorptiometry (FB DXA) has recently been validated for the measurement of body composition in small subjects. This study represents the first report