FDA accepts historical controls for epilepsy monotherapy studies
July 19, 2010 by admin · Leave a Comment
Major turning point in antiepileptic drug testing and development
New York University researchers revealed that data from previously completed withdrawal to monotherapy studies for antiepileptic drugs (AEDs) provide a valid control for future studies, obviating the need for placebo/pseudo-placebo trials to demonstrate the efficacy of these drugs as monotherapy. Results of this study are now available online in Epilepsia, a journal published by Wiley-Blackwell on behalf of the International League Against Epilepsy.
Hopkins faculty lead development of report to FDA on ethical, scientific issues related to ‘post-market’ clinical trials
July 13, 2010 by admin · Leave a Comment
Johns Hopkins Berman Institute of Bioethics plays prominent role
Amid growing concerns about clinical trials for drugs that have been approved by the F.D.A. but are later linked to serious health risks, an independent committee at the Institute of Medicine led by two professors from Johns Hopkins University has developed a conceptual framework to guide the agency through the tough decision of ordering such controversial “post-market” drug-safety trials.
FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests
Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn’t know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.
FDA should adopt risk-based approach to food safety
June 7, 2010 by admin · Leave a Comment
Contact: Christine Stencel
news@nas.edu
202-334-2138
National Academy of Sciences
WASHINGTON — The U.S. Food and Drug Administration’s abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks, says a new report by the Institute of Medicine and National Research Council.
FDA Approves Pancreatic Enzyme Product - Pancreaze
The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval.
Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.
FDA clears TransOral robotic surgery developed at Penn
January 3, 2010 by admin · Leave a Comment
Contact: Kim Guenther
kim.guenther@uphs.upenn.edu
215-200-2312
University of Pennsylvania School of Medicine Read more
FDA Orders Strong Warning Labels on Darvon, Darvocet
July 8, 2009 by admin · Leave a Comment
The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.
FDA Approves Simponi To Treat Rheumatoid Arthritis
The U.S. Food and Drug Administration (FDA) has approved a new drug known as Simponi to treat rheumatoid arthritis.
Simponi, known generically as golimunab, has been given the green light to treat three different types of arthritis in total.
FDA Approves Two Hologic HPV Tests
March 13, 2009 by admin · Leave a Comment
Hologic, Inc., (Hologic or the Company) (Nasdaq: HOLX), a leading women’s healthcare company dedicated to serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s premarket approval (PMA) applications for both the Cervista(TM) HPV HR (high risk) and the Cervista HPV 16/18 tests. Cervista HPV HR, designed to detect the 14 high-risk types of human papillomavirus (HPV) known to cause cervical cancer, is the first HPV DNA test approved by the FDA in more than 10 years. Cervista HPV 16/18 is the first HPV test approved for genotyping for HPV types 16 and 18, known to be associated with approximately 70% of all cervical cancers in the United States.
FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD
February 2, 2009 by admin · Leave a Comment
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved KAPIDEX(TM) (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor (PPI) with a Dual Delayed Release(TM) (DDR) formulation designed to provide two separate releases of medication.
