Navigation Links
FDA To Reconsider Standards for Reviewing Low-Dose Oral Contraceptives

FDA in documents released Thursday announced it is reconsidering its standards for reviewing the failure rate of new oral contraceptives with lower doses// of estrogen and progestin, the Wall Street Journal reports.

According to the Journal, higher pregnancy rates in studies of new low-dose oral contraceptives have instigated the agency to reconsider what represents an "acceptable failure rate" for new drugs. The agency uses a measurement called the Pearl Index, which calculates a contraceptive's failure rate by measuring the amount of time women are exposed to a given product and the number of unplanned pregnancies that result.

According to FDA documents, the agency in the 1970s set a policy that it only approved oral contraceptives with failure rates less than 1.5 per 100 "woman-years," or the number of years a woman has used the drug. FDA has recently approved some pills with failure rates of more than two per 100 woman-years, the Journal reports.

FDA said that the number of pregnancies in clinical trials has increased in new oral contraceptives with lower dosages of estrogen and progestin. The increase in pregnancies is "consistent with less sustained ovulation suppression in new products as compared to the earlier higher dose regimens," but there might be other reasons, FDA said.

Scott Monroe, acting head of the agency's reproductive-drugs division, said the variations between the new contraceptives and the old pills might "not be statistically different." According to the Journal, FDA in an upcoming meeting will seek its advisers' input for new guidelines to review new oral contraceptives.

Source: Kaiser Family Foundation
'"/>




Page: 1

Related medicine news :

1. Reconsideration Of Heart Transplant Eligibility
2. Reconsider Health Benefits of Organic Baby Foods, advices new study
3. Britain Reconsidering New Visa Rules for Indian Doctors
4. Court Orders NHS To Reconsider Funding Lung Cancer Drug
5. Researchers Feel The Need For Standards Of Practice In Immunoglobulin Therapy
6. DMAA to Develop Disease Management Standards by December
7. Setting Standards: Benchmark Medical Tests to Gauge Accuracy of Medical Tests
8. Medical Colleges, Confident of Meeting Standards Before 90-days deadline
9. Cleanliness Standards Dropped In NHS Hospitals – Patient Report
10. International Food Standards Meet Set For Chiang Mai Bangkok
11. Government Warned Against Dilution of Medical Standards
Post Your Comments:
(Date:7/31/2015)... , ... July 31, 2015 , ... Ticket Down is a reputable source of authentic ... MGM Grand Garden Arena. Fans of every genre of music will have an act ... the first day of the festival, the following artists will perform: Sam Smith, Coldplay, ...
(Date:7/31/2015)... ... 01, 2015 , ... Super Bowl 50 will emanate from Levi’s Stadium in Santa ... year is the Super Bowl. In the two weeks that separate the conference championships and ... The 2016 Super Bowl game will mark the 50th time it has been held and ...
(Date:7/31/2015)... ... July 31, 2015 , ... ... to know in predictive health analytics , Jvion continues to disrupt the ... creates predictive software that targets patient and population level illness to drive prevention ...
(Date:7/31/2015)... ... , ... Sculpted Contours Luxury Medical Aesthetics announces the arrival of the newest ... this new applicator in the United States as an upgrade to the CoolSmooth applicator ... original applicator required a 2 hour treatment time. The new CoolSmooth Pro reduces ...
(Date:7/31/2015)... Meadows, IL (PRWEB) , ... July 31, 2015 ... ... ways to communicate. Rally Insurance Group, Inc. has re-branded their social media profiles ... provides a personal way for consumers to communicate, find information, share insights and ...
Breaking Medicine News(10 mins):Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 3Health News:Cheap 2016 Super Bowl Tickets at Levi's Stadium: Ticket Down Slashes Ticket Prices on Super Bowl 50 Tickets in Santa Clara, CA at Levi's Stadium 2Health News:Jvion Showcased as Leader in the Predictive Analytic Market 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 3Health News:Rally Insurance Group, Inc. Connects to Customers Through Re-branded Social Media Profiles 2
... lower cholesterol levels, research shows they remain underused.// ... is in the hospital or at a follow-up appointment ... at the relationship between when lipid-lowering therapy is started ... and its long-term use. ,For the study, researchers ...
... and longevity to health status and quality of life. Researchers ... longer,// but the quality of life in later years must ... more benefits of staying physically active in your later years. ... able to perform their daily activities easier later in life. ...
... a primary long-term complication among premature infants suffering from ... for pulmonary hypertension and impaired growth, and they ... problems. ,A new study finds premature infants ... inhaled nitric oxide. ,Researchers from the University of ...
... focus of aging research has switched from mortality and longevity ... longer is it only important that one lives longer, but ... considered.” ,A new study shows more benefits of ... women who have an active lifestyle are able to perform ...
... Black, M.D., from Cedars-Sinai Medical Center in Los Angeles has ... While his research moves forward, he’s helping patients live longer ... Dr. Black says brain tumors try to ... system could use to recognize the tumor. By hiding these ...
... mothers who were depressed after childbirth are more likely to ... who lived in //South London. Mothers were interviewed during pregnancy ... They were also interviewed when their child reached 1, ... were questioned about violent symptoms when the child was 11 ...
Cached Medicine News:Health News:New vaccine for brain cancer 2
(Date:7/31/2015)... July 31, 2015  In today,s ever-changing marketplace, call ... increasingly mobile, increasingly connected, and increasingly impatient with slow ... customer interaction channels and tools is driving call centers ... According to research by benchmarking firm, ... (OTC) segment in a call center study realize the ...
(Date:7/31/2015)... 2015 More than 1,500 substance abuse prevention ... in Indianapolis Aug. 2-6 for ... Training Institute . The week-long training, held at the ... of our nation,s biggest public health challenges – youth ... is a one-of-a-kind intensive training opportunity, offering more than ...
(Date:7/31/2015)... , July 31, 2015 ... 2015 market research report that provides an overview ... using data sourced from in-house databases, secondary and ... and needles market products pipeline spread across 124 ... with 73 tables and 5 figures is now ...
Breaking Medicine Technology:Best Practices in Building World-Class Consumer & Over-the-Counter Call Centers 2Community Leaders From Across The Country Head To Indianapolis For CADCA 2015 Mid-Year Training Institute Aug. 2-6 2Syringes and Needles Market Products Pipeline Review 2015 Report 2Syringes and Needles Market Products Pipeline Review 2015 Report 3Syringes and Needles Market Products Pipeline Review 2015 Report 4Syringes and Needles Market Products Pipeline Review 2015 Report 5
... 2011 Company increases 2011 financial guidance ... Company increases 2011 financial guidance of adjusted diluted EPS to ... diluted EPS to be in a range of $2.43 to $2.53 ... year; Total annual revenues increase 17 percent versus prior year; ...
... 2011 /PRNewswire-Asia-FirstCall/ -- Dehaier Medical Systems Ltd. (Nasdaq: ... leader in the development, assembly, marketing and sale of ... announced that it has retained The Piacente Group ("TPG"), ... York, California and Beijing, to support the Company,s increased ...
Cached Medicine Technology:Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 2Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 3Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 4Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 5Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 6Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 7Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 8Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 9Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 10Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 11Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 12Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 13Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 14Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results 15Dehaier Medical Retains The Piacente Group as Strategic Investor Relations Consulting Firm 2Dehaier Medical Retains The Piacente Group as Strategic Investor Relations Consulting Firm 3
... The determination of Ang ... in monitoring the pharmacological effect ... variety of angiotensin converting enzyme ... II receptor antagonists as well ...
Anti-RSV IgG Assay (ELISA)....
Rapid, visual assay for the presumptive qualitative detection of Respiratory Syncytial Virus (RSV) directly from nasopharyngeal specimens in neonatel and pediatric patients....
Qualitative ELISA for the detection of rotavirus antigen....
Medicine Products: