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:
*Name:
*Comment:
*Email:


(Date:4/28/2017)... ... April 28, 2017 , ... Datta Endoscopic ... has joined the revolutionary endoscopic practice under Dr. Datta. Patel is a Board ... Medicine. The patented, revolutionary eDiscSculpt Technique created and used by Datta Endoscopic is ...
(Date:4/28/2017)... ... April 28, 2017 , ... From April 30 to May ... Medicine will host industry leaders for the annual spring Convention & Expo, called ... industry adapt to the issues currently affecting urgent care and on-demand healthcare. , ...
(Date:4/28/2017)... Diego, Ca (PRWEB) , ... April 28, 2017 , ... ... property management industry in the coastal communities. After Tina Howe joined the team, the ... and happy employees, honest services at affordable rates, and giving back to the San ...
(Date:4/28/2017)... ... April 28, 2017 , ... Phytomer USA is pleased ... has 20+ years of experience within the beauty industry, ranging from marketing, retail ... of high-end cosmetic brands, retail brands and outlets in Canada and New York. ...
(Date:4/28/2017)... ... 28, 2017 , ... NuevaCare, a leading home care agency based in San ... Alto, is proud to announce information upgrades to its blog in the form of ... on topics such as home care (generally) as well as senior care and home ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... , April 19, 2017  SARES•REGIS Group ... it is developing at Conejo Spectrum Business Park ... to Atara Biotherapeutics, Inc. , a biopharmaceutical ... and life-threatening diseases that have been underserved by ... T-cell therapies for cancer, autoimmune and infectious disease. ...
(Date:4/18/2017)... Cogentix Medical, Inc. (NASDAQ: CGNT), a global medical device ... markets with innovative and proprietary products, will release financial ... after the market close on Tuesday, May 2, 2017. ... call and webcast to discuss its financial results the ... p.m. Eastern Time (3:30 p.m. Central Time). Darin ...
(Date:4/18/2017)... -- Research and Markets has announced the addition of ... offering. ... market to grow at a CAGR of 6.35% during the period ... has been prepared based on an in-depth market analysis with inputs ... growth prospects over the coming years. The report also includes a ...
Breaking Medicine Technology: